Therapeutic Products Directorate

2006-2007

Date: 2007-12-27

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Table of Contents

• Message From The Director General
• What We Do
• Who We Are
• Vision/Mission
• Our Values
• Our Strategic Context
• Our Strategic Objectives And Priorities For Action

1. Strategic Objective: Modern Regulatory Framework
Progressive Licensing Project
Schedule A
Clinical Trial Registration And Disclosure

2. Strategic Objective: Performance Sustainability
Performance Review
Project/Workload Management
Good Guidance Practices
Good Review Practices
Enhanced Review Capacity
Summary Basis Of Decision
Product Monograph Project
E-Review
Special Access
Clinical Trials/ Investigational Testing
Pandemic Influenza

3. Strategic Enabler: Governance

4. Strategic Enabler: People
Training

5. Strategic Enabler: Relationship Management
Bilateral Meeting Program
International Regulatory Cooperation
International Harmonization
Communications

Future Plans For 2007-2008

1. Strategic Objective: Modern Regulatory Framework
Progressive Licensing Project
Schedule A
Clinical Trial Registration And Disclosure

2. Strategic Objective: Performance Sustainability
Review Performance
Project/Workload Management
Good Guidance Practices
Good Review Practices
Enhanced Review Capacity
Summary Basis Of Decision
Product Monograph
E-Review
Special Access Program
Clinical Trial/Investigational Testing
Pandemic

3. Strategic Enabler: Governance

4. Strategic Enabler: People
Training

5. Strategic Enabler: Relationship Management
Bilateral Meeting Program
International Regulatory Cooperation
International Harmonization
Communications

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Message From The Director General

I am pleased to present the Therapeutic Products Directorate's (TPD) first Annual Progress Report, which outlines our progress and accomplishments over the past fiscal year in support of our strategic plan. Throughout the 2006-2007 fiscal year, TPD has continued to help Canadians maintain and improve their health through the regulation of pharmaceuticals and medical devices. Building on our past success, we remain committed to ensure that we are well positioned to continue this success into the future.

The TPD Strategic Plan- The Way Forward- helps define our future direction, plan and measure results, and ensures alignment with other areas of Health Products and Food Branch. It also emphasizes our commitment to improve our work environment and to ensure the strategic management of our resources. The Way Forward is a "living" document that will evolve as we achieve goals and respond to emerging trends, challenges and opportunities. The strategic plan includes two strategic objectives: "Modernization of the Regulatory Framework" and "Performance Sustainability," and three strategic enablers: "Governance," "People" and "Relationship Management." Effective communication is an overarching element of the plan. By focusing on these key objectives and enablers, we will ensure that we continue to develop our business and people to move forward in the right direction.

It is with great pleasure that I present to you the TPD Annual Progress Report and welcome you to join in our successes.

Supriya Sharma

What We Do

The Therapeutic Products Directorate (TPD) is the Canadian federal authority that regulates pharmaceuticals and medical devices for human use. Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality. This evidence is reviewed by scientists and physicians to determine whether the potential risks from the products are acceptable when balanced against the benefits for the product's proposed use. The legislative framework under which TPD operates includes the:

• Canada Health Act.
• Food and Drugs Act (Food and Drug Regulations, Medical Devices Regulations).
• Patent Act (Patented Medicines (NOC) Regulations and Data Protection).
• Financial Administration Act (Cost Recovery Fee Regulations).
• Access to Information Act and Privacy Act.
• Controlled Drugs and Substances Act.
• Public Service Modernization Act.

TPD develops and administers regulations and policy to:

• Review Clinical Trial Applications for pharmaceuticals and Investigational Testing for medical devices to ensure the studies are properly designed and that participants will not be exposed to undue risk.
• Conduct a review of scientific information to evaluate the safety, efficacy and quality of a pharmaceutical, disinfectant or medical device and assess the potential benefits and risks of the product.
• Review information that the manufacturer intends to provide to health care practitioners and consumers about the product.
• Provide access to non-marketed drugs/medical devices to practitioners treating patients when conventional therapies have failed, are unsuitable, or unavailable.
• Provide Canadians with science-based information they need to make informed choices.
• Monitor and review health product safety and effectiveness information as it becomes available to ensure the benefit/risk balance remains acceptable.
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Who We Are

The TPD team includes over 500 scientists, doctors, technicians, analysts, administrators and managers, all dedicated to the work, principles and purpose of TPD. The directorate consists of offices and bureaus that report to the Director General.

• Director General's Office.
• Medical Devices Bureau.
• Submission and Information Policy Division.
• Office of Business Transformation.
• Office of Clinical Trials.
• Office of Patented Medicines and Liaison.
• Office of Risk Management.
• Bureau of Cardiology, Allergy and Neurological Sciences.
• Bureau of Gastroenterology, Infection and Viral Diseases.
• Bureau of Metabolism, Oncology and Reproductive Sciences.
• Bureau of Pharmaceutical Sciences.
• Bureau of Policy, Science and International Programs.

Partners and Stakeholders

Regulating therapeutic products and making them available to Canadians is a shared responsibility. TPD works closely with its Health Canada partners as well as other regulatory agencies and the provincial and territorial governments. TPD also collaborates with scientists and agencies around the world, such as the United States' Food and Drug Administration and Australia's Therapeutic Goods Administration, who share our interests and goals.

As reflected in the strategic plan, TPD encourages an environment of collaboration that is built on common understanding of roles and responsibilities and which facilitates information sharing and building effective relationships with its partners and stakeholders. TPD's stakeholders include patients and consumers, health care professionals, research scientists, industry, academic institutions, pharmacies, hospitals, regulatory scientists and policy makers.

The development of these mutually beneficial relationships assists TPD in fulfilling its legislative mandate, delivering programs, launching new initiatives and building public trust.

Vision

TPD is recognized as a world-class regulator of pharmaceuticals and medical devices with strong leadership and a skilled collaborative workforce that makes major contributions to the Canadian health care system and to the health of Canadians.

Mission

TPD contributes to the health of Canadians and to the effectiveness of the health care system by regulating pharmaceuticals and medical devices and by providing Canadians with access to information to make informed choices.

Our Values

Our corporate values are the standards by which our actions and decisions are to be considered and judged by others. TPD undertakes its work based on principles of effectiveness, efficiency, transparency, accountability and cooperation. The values of TPD reflect those of Health Canada.

• Taking Pride in What We Do - TPD employees are motivated and guided by their personal integrity.
• Building a Workplace Community - TPD employees respect each other and work together in a healthy environment.
• Caring for the People of Canada - TPD advances the public good with purpose and commitment while honouring democratic values.
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Our Strategic Context

Effective strategic planning requires a thorough review of an organization's internal and external drivers and trends, with an eye to identifying current and future challenges and emerging opportunities. In developing its strategic plan, TPD undertook an in-depth environmental scan that included a review of domestic and international pharmaceutical and medical device industry developments and trends as well as surveys of TPD employees and HPFB managers.

Legislative reform, globalization of the pharmaceutical and medical devices industries, science and technology changes and new discoveries, international regulatory collaborations, and changing expectations of Canadians for information, openness and transparency represent just a few of the challenges on our horizon. TPD has the expertise, credibility and regulatory know-how to meet these challenges and to seize new opportunities that they may bring.

External Drivers and Trends

One of the key external factors impacting TPD business today and into the future is the changing business model of which globalization, competition and protection of intellectual property are main drivers. Additional factors include the growth in drug spending, driven by both the aging population and ever-rising costs; the increasing complexity of medical devices; and strengthened efforts to monitor and manage adverse drug reactions.

For TPD's business, these and other factors are expected to lead to higher volumes of submissions/applications and increased pressures related to meeting performance standards.

Internal Drivers and Trends

The 2005 TPD Change Management Survey and Survey of Senior and Middle Managers in HPFB identified a number of current strengths and vulnerabilities of the directorate. The dedication of TPD's staff and its scientific and regulatory expertise are key strengths that have supported the successful elimination of the backlog, the development of improved relationships and collaborations with other areas of the branch, a positive international profile, and have earned the confidence of stakeholders and Canadians.

Internal governance issues including leadership, priority setting, the changing regulatory environment that demands more consultation, access and transparency, and the renewed public service requirements for accountability, are other important factors driving how TPD must operate in the future.

Workforce renewal, succession planning, greater teamwork and improved collaboration with other branch directorates are among the strategies designed to respond to these challenges and to capitalize on opportunities.

Our Strategic Objectives and Priorities For Action

The Way Forward is focused around strategic areas that reflect TPD's commitment to providing Canadians with excellent and timely decisions on pharmaceuticals and medical devices. They help provide TPD with the flexibility to respond to emerging challenges and to maximize new opportunities. The strategic areas also reflect TPD's commitment to ensuring its employees have the skills and knowledge to work productively and effectively. The regulatory science-based excellence that forms the foundation of TPD is an underlying guiding principle of all strategic areas.

The strategic plan includes two strategic objectives, "Modernization of the Regulatory Framework" and "Performance Sustainability" and three strategic enablers: "Governance," "People" and "Relationship Management." Effective communication is an overarching element of the plan.

1. Strategic Objective: Modern Regulatory Framework

By focusing on ways to improve and modernize the regulatory framework, TPD will contribute to Health Canada's commitment to speed up the regulatory process and to improve health outcomes for all Canadians.

A modern regulatory framework, in addition to providing improved access to therapeutic pro-ducts for Canadians, will help provide the flexibility needed to respond to today's needs and be adaptable to future needs. A modern regulatory framework will be based on sound risk management that supports access to promising new therapies and technology while continuously monitoring and reassessing for potential safety, quality, efficacy and effectiveness concerns throughout the product life cycle.

The following activities outline progress that has been achieved during the 2006-2007 fiscal year towards Strategic Objective: Modern Regulatory Framework.

Progressive Licensing Project

The Progressive Licensing Project is a key element of Health Canada's Blueprint for Renewal, a plan to modernize the regulation of health products and food in Canada. Through Progressive Licensing, Health Canada is developing a modern drug licensing framework consisting of laws, regulations and guidelines that will support timely access to drugs and provide mechanisms for the continuous monitoring and reassessment of a drug's safety, quality and effectiveness throughout its life cycle.

• Forums were organized for internal stake holders to learn about Progressive Licensing and to contribute to the development of the framework.
  
  
• A stakeholder engagement strategy was established that promoted the early involvement of a broad range of stakeholders in the development process. A number of events, unique in format for the branch, took place and were positively received by participants. Their feedback has been extremely helpful in moving forward with refining concepts and proposals for a detailed framework.
  
  
• The Progressive Licensing Concept Paper has been launched.
  
  
• The Progressive Licensing Web site was developed throughout the course of the year and launched in April, 2007. This Web site contains information on the project, why it is being done, and how people can get involved with the process. It also contains the concept document, brief discussion papers on topics relating to the regulation of drugs, and reports of workshops with stakeholders.

Schedule A

Schedule A to the Food and Drugs Act is a list of diseases (e.g. cancer, heart disease, gout) for which preventative, treatment and cure claims in labelling and advertising to the general public are prohibited by section 3 of the Act.

• Project 1474, a proposed regulatory amendment to permit certain Schedule A claims, was prepublished in Canada Gazette, Part I, on November 19, 2005.
  
  
• A Scientific Advisory Panel (SAP) was convened on September 21, 2005 to review the disease listings in Schedule A. The Record of Proceedings was finalized by the SAP, and was posted on the Health Canada Web site on March 29, 2006.
  
  
• As Health Canada was preparing to finalize Project 1474, the department was also considering the recommendations made by the SAP to revise Schedule A. It became evident that such revisions should take place before or at the same time that any section 3 prohibitions were lifted.
  
  
• Therefore, the department was preparing to withdraw Project 1474 and to propose Project 1539, a regulatory amendment to permit certain Schedule A claims and to revise Schedule A.

Clinical Trial Registration And Disclosure

There is currently no general requirement in Canada for sponsors to disclose, in a public forum, the existence of ongoing or completed clinical trials, or to summarize and report the results of clinical trials that have been undertaken. It has been widely acknowledged that registration and disclosure of clinical trial information in a publicly available registry would increase public access to information about clinical trials.

• Building on results of the 2005-06 consultations which were aimed at clearly identifying the issues and stakeholder needs, in 2006-07 Health Canada convened the first meeting of the External Working Group to develop preliminary options for public consultation. In developing the preliminary options, the External Working Group considered international and domestic initiatives as well as results of Health Canada's 2005 public consultations. An online work book was developed for the purposes of external consultation to obtain public input on policy options developed by the External Working Group for improving access to information on clinical trials.
  
  
• External consultations with the public were held throughout June and July of 2006 and teleconferences of the External Working Group were held in October 2006 in order for members to consider input from the June-July public consultation and revise their recommended options. Health Canada summarized and posted results of the 2006 public consultation to the Health Canada website. The External Working Group's Final Report was received and posted, which included recommendations to Health Canada on how to proceed with the registration and disclosure of clinical trial information in Canada. Health Canada began development of an Issue Analysis Summary outlining the issues, analysis and recommended option for implementation in early 2007. The purpose of this document is to analyse the input from the various public consultations and the recommendations of the External Working Group to determine how Health Canada could address the issues initially identified in the 2005 public consultations.
  
  
• Throughout the year, Health Canada continued to monitor and, where appropriate, participate in numerous registration and disclosure initiatives that are underway world wide.
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2. Strategic Objective: Performance Sustainability

TPD's regulatory approach is based on the idea that quality reviews lead to quality decisions, achieved through the application of excellence in regulatory science. TPD is committed to meeting or exceeding its performance standards for timely and quality decisions. Through this strategic objective, TPD will ensure its regulatory processes and policies continue to enable timely, consistent, transparent, predictable and sustainable reviews.

The following activities outline progress that has been achieved during the 2006-2007 fiscal year towards Strategic Objective: Performance Sustainability.

Performance Review

The 2002 Speech from the Throne included a commitment to improve the timeliness of the regulatory process for therapeutic pro-ducts to ensure that Canadians have faster access to the safe drugs they need. In support of this commitment, the budget of 2003 provided funding over five years to improve the timeliness of Health Canada's regulatory processes while preserving the principle that safety is of paramount concern. September 2005 marked a major milestone for performance as we reached our target of 90% of reviews completed on time for new pharmaceutical drug submissions. Continuing on this success, and consistent with internationally comparable performance targets, in 2006-2007 Health Canada met its goal of maintaining and was able to sustain on an ongoing basis its 90% review on time performance goal for not only new pharmaceutical drug submissions (157 approved) but also for generic drug submissions (105 approved).

Progress on the Medical Device side was very impressive, with Class III and IV decisions not only meeting the 90% performance target, but rather exceeding the target by reaching 95%. The result for Class II applications was 81% within performance target, mainly due to staff shortages and increased submission levels. The second phase of the process review has been initiated where process improvements to key application work flows are being identified and implemented. Value stream process mapping exercises were conducted to identify non-value added process steps for elimination. For the Class II application process, improvement options included the use of computerized fax forms, earlier triage to return deficient applications sooner, as well as the inclusion of a request for labels in the application form and/or guidance. For the ITA (Investigational Testing Application) process, new process maps and opportunities for improvement were noted for analysis, discussion and possible implementation in 2007. As well, the Special Access Program process was mapped and as a result, a modified application form was created, two work streams were merged into one, and an unnecessary mail-out was eliminated, thus saving valuable time and money.

In support of the above performance, work continues for the review process with appropriate and enhanced review guidance, procedures and templates including updating the Class III and IV device and In Vitro Diagnostic Device review templates. This includes revisions and updating of various types and classes of screening templates. In 2006, revisions were also made to the investigational testing standard operational procedure and an executive summary template was developed and launched. Under the Good Guidance Practices initiative, five new guidance documents including guidance on key word index, use of standards, hospital beds, sterilization, and ISO 13485:2003 under CMDCAS were posted. The group has also launched a project with the members of the industry group Medical Devices Canada (MEDEC) to help identify and completing guidance documents in a collaborative manner that will benefit applicants and industry.

Project/Workload Management

First implemented in 2003, Project Management is expected to generate review process improvements so that the review team can operate in a more effective and efficient manner. Through project management approaches, product submissions are managed as projects with the necessary planning, coordination and management of activities to oversee completion of reviews within performance targets. The intended outcome of project management is to achieve high-quality reviews and reports within performance targets. The project management approach ensures that appropriate review targets are set and monitored for each submission/application, issues are identified early, actively dealt with and resolved and the submission/application is not delayed. Also, one person (the Regulatory Project Manager) always knows the status of the submission/application and is responsible for communicating its progress, both internally and externally. The intended outcome of project management is to achieve high quality reviews and reports within performance targets.

Working in conjunction with the Project Management Initiative, the Workload Management Initiative endeavours to manage the TPD workload related to the drug review process. It provides a snapshot via the Drug Submission Tracking System of how many drugs are being reviewed and the current backlog at any given time. This initiative provides an ongoing assessment of the progress of review on each submission and insight on workflow trends in order to take proactive measures. The current focus is on all submission types with specific emphasis on new drugs.

Project Management

• The Project Management Initiative continues to make significant progress towards achieving its targets and goals. The Regulatory Project Management Division staff contributed significantly to TPD's achievement of its goal to review 90% on time. New Regulatory Project Manager (RPM) positions were filled to address the expanding need and bring the current count to 20 Regulatory Project Managers that service TPD.
  
  
• Positive feedback continues to be received by both our internal and external clients. The progress of the initiative has prompted increased dialogue on proposed submission filings, progress of submissions, and on internal processes with the aim to enhance workload management planning and process efficiencies. External clients continue to observe the link between the introduction of RPMs and the timely completion of submission reviews. The importance of the enhanced communication and timely response time on queries continues to be a key message by external clients.
  
  
• A review plan is created for each submission that is received. This is an ongoing activity which has gained support from each of the review bureau management teams. The internal working group described above further defines obtainable milestones and upfront identification of the review team members.
  
  
• Revisions to the Work Breakdown Structure (WBS) are made on an ongoing basis as process improvements take place. An internal working group has created a standard abridged version of the Submission Review WBS and a subset of this abridged version is currently being explored for new drug submissions and for subsequent market entry products.
  
  
• The RPM training program is continuously being developed and strengthened to encompass training on regulations, policies, general review process procedures, the pharmaceutical environment, project management, and soft skills needed to deliver the service that is expected of the Regulatory Project Management Division.
  
  
• Based on the brainstorming sessions, a SOP needs analysis and its prioritization for the two sections of the division was collected and assessed. A development plan for the RPM SOPs has been created and similarly, this will be done for the Submission Coordinator SOPs. Two Master SOPs were developed, approved and finalized and seven other Master SOPs are currently in draft form (waiting for internal comments). The development of SOPs is an ongoing activity that will continue throughout the next fiscal year.

Workload Management

Workload Reporting:

During 2006-2007, the twice-monthly reports were expanded to include screening performance in addition to review performance as well as reporting on Notifiable Changes and DIN ("not new" drug) submissions. These reports were issued to the Senior Regulatory Project Managers and provided detailed information around the following indicators:

• Age stratification of the current workload.
  
  
• For incoming submissions each year, the number of NDS', Screening Deficiency Notices, Notices of Deficiencies and Notices of Non-Compliance issued relative to total.
  
  
• For incoming submissions each year, the number of NDS' meeting performance targets relative to total (90%).
  
  
• Backlog stratification by age.

Throughout the next year, reporting capabilities will continue to be developed and additional performance indicators will be pursued.

Workload Management Forum:

A Workload Management Forum continues to be held on a monthly basis. This monthly meeting gathers together the Director General, the Review Bureau Directors, the Review Division Managers and the Senior Regulatory Project Managers in a full discussion of the new drug submission, NC and DIN workload. This regular meeting permits an accounting of full workload, the sharing of best practices and challenges in a collaborative and collegial environment. It also provides an opportunity for work sharing to address workload issues. Focused discussion sessions were introduced in the Workload Management Forums as required.

• No. of Workload Management Forums held in 2006-07: 11.
• No. of Workload Reports prepared in 2006-07: 22.
• Focused discussion sessions:
  • Reconsideration process: 2.

TPD Management Committee Meetings:

A higher level presentation is also made monthly to the Directorate Management Committee.

• No. of Submission Workload presentations to TPD-MC in 2006-07: 11.

Good Guidance Practices

The Good Guidance Practices Initiative (GGP) creates a common process for the development of all documents providing guidance to staff and stakeholders. GGP ensures that all internal and external guidance documents are fully supported by our regulatory framework and international obligations, and are written in a consistent format with suitable language.

Consistent guidance documents that have been developed and communicated appropriately will improve the quality of drug submissions and medical device applications. GGP will contribute to the consistent, predictable interpretation of the Food and Drugs Act and Regulations by TPD and BGTD staff, and will therefore support a more efficient, predictable and timely review process.

• Over the last half of FY 06/07, the GGP project transitioned from the Office of Business Transformation to the Bureau of Policy, Science and International Programs (BPSIP) for implementation.
  
  
• The GGP Working Group drafted the GGP Manual, intended to be an electronic resource for issue analysis and guidance development in TPD and BGTD. The manual has chapters for Guiding Principles, Definitions, Roles and Responsibilities, Procedures, Templates, a Style Guide, and a Lexicon. It underwent external consultations in the fall of 2006 and has been revised accordingly.
  
  
• Training is on-going and informal communication was conducted internally as part of the consultations on the GGP Manual. Externally, updates on the project have been given at TPD- and BGTD-industry association bilateral meetings.
  
  
• A guidance inventory was undertaken within the GGP WG, building on the existing Metatag database in TPD/BGTD. The inventory contains every document posted on the TPD and BGTD Web sites, plus additional documents providing guidance.
  
  
• The needs assessment exercise that began in 2004 with internal and external input continued through FY 06/07. The Working Group prioritized the list of guidances needed, guidances to be revised, and guidances from other jurisdictions to be considered for adoption, and presented the list to TPD-MC. The Needs Assessment will require updating on a regular basis to reflect changing priorities, expectations and resourcing.
  
  
• Ongoing guidance development has proceeded according to Good Guidance Practices, informally piloting the implementation of the GGP Manual.
  

Good Review Practices

The Good Review Practices (GRP) Initiative was undertaken to create a coordinated approach to the development of all review standards. Good Review Practices are review standards (such as standard operating procedures and templates) and related initiatives (such as reviewer manuals and training programs) designed to ensure the timeliness, predictability, consistency, and high quality of reviews and review reports. The Good Review Practices Project is the umbrella; the development of review standards and related initiatives are the sub-projects under the umbrella.

• Both the GRP intranet for staff and Web page for the public were launched during FY 06-07. Since all Health Canada reviewers have access to the GRP Intranet, it has become the primary internal communication tool for information on Good Review Practices. It now contains all materials and thousands of links to resources for review staff.
  
  
• Development of SOPs, templates, reviewer orientation and training is ongoing.

Enhanced Review Capacity

The Enhanced Review Capacity Initiative involves building internal scientific capacity as well as appropriate use of expert advice from external sources, such as drug or disease experts, professional associations, scientific advisory panels and committees or academic institutions.

This Initiative is made up of two components. The first deals with the creation and maintenance of scientific advisory bodies, such as Scientific Advisory Panels (SAP) and Scientific Advisory Committees (SAC). The second relates to the centralization of scientific contractual services to expedite reviews. As part of our business process improvements, we have focused on developing an efficient contracting modality, which includes a more streamlined and efficient process within a targeted client-service environment.

The following are some of the specific achievements of the Enhanced Review Capacity Initiative.

In relation to Scientific Advisory Bodies in FY 06-07.

Standing Committees:

• Two meetings and one teleconference were held for the Scientific Advisory Committee on Respiratory and Allergy Therapies.
  
  
• Two meetings were held for the Scientific Advisory Committee on Medical Devices used in Cardiovascular Systems.
  
  
• One teleconference was held for the Scientific Advisory Committee on Oncology Therapies.

Advisory Panels:

• One meeting was held for the Scientific Advisory Panel on Bioequivalence Requirements for Fentanyl Transdermal Delivery Systems.
  
  
• One teleconference was held for the Scientific Advisory Panel on Hepatotoxicity.
  
  
• Two meetings and four teleconferences were held for the Scientific Advisory Panel on Reprocessing of Medical Devices.

In relation to the Enhanced Contracting Capacity:

Expert Advisory Database- Development & Implementation:

• A Letter of Invitation, external Web site and on-line application form have been finalized and are now live on the Internet. (www.healthcanada.gc.ca/erci)
  
  
• Further software development continued in support of the database implementation. Testing took place and corrections were made. Unfortunately there were still further enhancements required to take advantage of full functionality so with additional funding internal IT staff were assigned to bring the database to fruition.
  
  
• Final fixes were made by April 07 with a launch planned for late spring. This launch is intended to introduce our clients to the database with a demonstration of its functionality and the provision of a user manual. After this demonstration, deployment to desktops will begin.

Internal Contacts:

• Several Review Bureau Directors and other TPD staff have provided names and CVs of individuals who may be potential contractors for TPD. These CVs are being gathered and these individuals will be added to the mailing list. Internal staff continue to be canvassed for potential additions to the inventory.

External Contacts:

• A marketing brochure was finalized and mailed to over 1,000 potential applicants. This brochure provides more detailed information on what we do and provides the Web link/URL for on-line registration.
  
  
• An outreach strategy and communications plan is being developed to increase the inventory. A list has been developed of specific specialties that will enhance the inventory and we are planning to contact specific organizations to fulfill this need. As well, attendance and distribution of our brochure at conferences, workshops, seminars etc, has helped spread the word and attracted many scientific experts interested in working with us.

Process Training:

• Meetings have taken place with several clients/ Review Bureaus to review the contracting process and advise of roles and responsibilities. We also continue to gather information on best practices and lessons learned within the past year regarding contract management. A client satisfaction survey was conducted with good results.

Summary Basis Of Decision

The Summary Basis of Decision (SBD) Initiative was developed in response to Health Canada's commitment to enhance the transparency of the drug and medical device regulatory review process.

A Summary Basis of Decision document outlines the scientific and benefit/risk based decisions that factor into Health Canada's regulatory decision to grant market authorization for a drug or medical device. The document includes regulatory, safety, efficacy and quality (chemistry and manufacturing) considerations. SBDs are written in technical language for stakeholders interested in product-specific Health Canada decisions, and are a direct reflection of observations detailed with reviewer reports. Implementation will take place in a phased approach beginning with New Drug Submissions (NDS) for New Active Substances (NAS) and a subset of Class IV medical device applications.

Summary Basis of Decision Implementation:

• Subsequent to Phase I implementation in January 2005, SBDs continued throughout FY 06-07 for NAS NDSs and a subset of Class IV medical device applications. During fiscal 2006-2007, 33 Notices of Decision (ND) and 25 Summary Basis of Decision (SBD) documents were published for pharmaceuticals, biologics, and medical devices. The SBD Web page (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/index-eng.php) was re-organized to provide more information in a more user-friendly format. The Notice of Compliance (NOC) database was updated to include NDs and SBDs.

Product Monograph Project

The Product Monograph Project was initiated to undertake a comprehensive revision of the format and content of the product monograph, including a new consumer information section. Product monographs prepared in accordance with the revised guidance provide more comprehensive information on the benefits and risks of products to assist health care professionals and consumers to make informed treatment choices.

Consumers and health care professionals participating in stakeholder consultations indicated that they want information about drugs that is objective, responsible and credible. The product monograph is the obvious source for this information as it represents the conditions of marketing authorization for the product. Accordingly, the Product Monograph Project is developing a plan to make product monographs publicly accessible.

Revised Product Monograph Implementation:

• As of October 1, 2004 all product monographs submitted as part of a submission were required to be in the revised format. Implementation of the new format was revisited in May, 2006 to address challenges from sponsors in completing template requirements for particular submission types.

Dissemination of the Product Monograph- Public Availability:

• The Product Monograph Working Group completed its analysis in the development of a proposal addressing issues involved in making product monographs publicly accessible. Internal feedback was solicited on proposed options during the summer of 2006.
  
  
• In 2006/07, Health Canada commenced with an interim measure to make product monographs available upon request, as per procedures outlined in the May 29, 2006 Notice entitled: "Transparency: Direct Release of Product Monographs to Requesters" and through the Access to Information Act process.

E-Review

The E-Review Initiative aims to establish an electronic review environment in-line with international standards that will offer Information Management and Information Technology (IM/IT) tools, provide support to the electronic submission and increase efficiency of the review of health products that Health Canada regulates.

E-Review includes a number of IM/IT solutions such as:

• Handling electronic based submissions for therapeutic products.
  
  
• Special Access Program System.
  
  
• Clinical Trail Adverse Drug Reaction System.
  
  
• Tracking and electronic workflow of therapeutic product submissions.
  
  
• Electronic Product Monograph System.
  
  
• Secure Gateway (submission on-line).

E-Review started in April 2003 as a five-year project and is currently in its fifth year.

The following are some of the achievements of the E-Review Initiative:

• The in-house interim viewing tool (IIVT) software solution for Electronic Common Technical Document (eCTD) format has been enhanced and support has been provided. On demand training was provided throughout the year, which allowed TPD and BGTD to review eCTD format submissions electronically in both paper/electronic co-submission and hybrid filing formats.
  
  
• The long-term viewing tool solution (docuBridge) has been acquired, configured, implemented and deployed in a pilot environment to support the management and review of electronic submissions:
  • All eCTD submissions have been migrated from the IIVT to docuBridge.
  • Training has been initiated on an 'on demand basis' (When eCTD submissions are received and assigned, reviewers are trained).
  • Wide screen monitors were acquired and installed to facilitate the use of docuBridge^®.
  • Both new and updated licenses have been acquired for Adobe Acrobat Professional Version 7 for all review staff.

A training strategy was put in place to support the implementation of docuBridge, Adobe Acrobat, and the use of the eCTD format by developing the following material:

• Lesson plan.
• Instructor manual (training script).
• Participant Guide (training guide for docuBridge and Adobe Acrobat).
• Quick reference guide for docuBridge.
• Presentation to introduce working with eCTD.
• Reference guide: Working with eCTD.
• Training evaluation form.
• Post training follow-up strategy.

• The Office of Information Management and Technology Infrastructure Lab which was built to support the technical design, testing and Proof of Concept (PoC) functions of different E-Review solutions was re-organized to support the delivery of the training;
  
  
• The following standard operating procedures were developed:
  
  
  • Handling and validation of submissions in eCTD Format.
  • Technical pre-submission meeting.
  • Hybrid pilot selection & acceptance.
  • Hybrid printing.
    
    
• A process map was developed for the management and review drug submission in eCTD format.
  
  
• The eCTD validator was acquired, configured and implemented.
  
  
  • Developed eCTD validation rules.
    
    
• 311 sequences were validated and registered.
  
  
  • NDS 5 (118 sequence).
  • SNDS 8 (51 sequences).
  • ANDS 23 (110 sequences).
  • NC 15 (20 sequences).
  • Invalid sequences: 12.
    
    
• The hybrid filing format pilot has been implemented. This is a submission in electronic format that is accompanied by a partial paper-based submission in CTD format, Modules 1 and 2 only.
  
  
• The transition to a single tracking system has been completed by integrating submissions received by Veterinary Drug Directorate.
  
  
• The Secure Highway infrastructure has been implemented by CSB/IMSD.
  
  
• The Drug Submission Tracking System has been enhanced to enable the tracking of eCTD format submission.
  
  
• The Clinical Trials Adverse Drug Reaction Tool was implemented for BGTD (LABWARE).

Special Access

Health Canada, through its Special Access Program (SAP), allows practitioners to gain access to unauthorized drugs and medical devices that have not yet been approved for sale in Canada.

Practioners treating patients with serious or life-threatening conditions request Special Access in cases where conventional therapies have failed, are unavailable or are unsuitable.

The SAP Comprehensive Review is multi-faceted, involving an operational review to evaluate how the program is functioning within its existing framework, and an ethics review to study the ethical context of the mandate and activities of the SAP. The projects, as well as the finalization of a SAP guidance document for current processes, and ongoing work on a regulatory amendment to permit the block release of non-marketed drugs for health emergency or bio-defence situations, will inform a broad policy review aimed at modernizing the program.

SAP Guidance Document

• Conducted broad internal consultation, including presentation to the Branch Executive Committee in January 2007.
  
  
• Posted the draft SAP guidance document on January 18, 2007 for a 60-day external comment period.

SAP Regulatory Amendment-Block Release

• Revisions have been made to the Issue Analysis Summary/Option paper based on consultation feedback.
  
  
• A triage questionnaire has been submitted and signed by Treasury Board Secretariat (TBS).
  
  
• A Regulatory Impact Analysis Summary (RIAS) has been submitted to TBS, however it is under revision. We are currently awaiting Legal feedback to finalize the RIAS.

SAP Comprehensive Review

• Met with the Comprehensive Review Steering Committee in February 2007.
  
  
• Met with a Science Advisory Board.
  
  
• Presented to ADM's F/P/T meeting.

SAP Operational Review

• Developed sole source contract for SAP operational review.
  
  
• Hired a contractor to develop a report.

SAP Ethics Review

• A team of two ethicists was contracted to develop a discussion paper about the ethical dimensions of the mandate and activities of the SAP.

Clinical Trials/ Investigational Testing

As part of Health Canada's initiative to strengthen the safety system for therapeutic products, we continue to strengthen the oversight of pharmaceutical clinical trials and investigational testing for medical devices conducted in Canada, as well as access points for patients to new and innovative therapies. Clinical trials and investigational testing provide the evidence of safety, efficacy and quality required by the regulations before a product may receive a general market authorization from Health Canada as well as access points for patients to new and innovative therapies.

• During fiscal 2006-2007, the department continued to see an increasing volume and complexity of incoming safety information and work continued toward building sufficient tools and expertise to identify and respond to safety concerns. With investments, Health Canada was able to enhance its regulatory review capacity by five new staff to address significant increases in incoming drug clinical trial applications (CTA), and three new staff for clinical trial adverse reaction reports (ADR) and safety reports from domestic and international sources in order to ensure timely response and appropriate communications/linkages with pre-market reviewers and post-market surveillance areas.
  
  
• The workload in FY 2006-2007 for CTAs and CTA-As was 2,617; for CTA-ADRs 34,579 and there were 105 safety signals of which only 25 were successfully analyzed. There were also 13 pre-clinical trial application meetings. Although the CTA-ADR unit enhanced its capacity this year, there are still insufficient resources to meet the current demands. These are in comparison to the workload reported in FY 2005 - CTA 2,645, ADRs 28,500; safety signals 14.
  
  
• In addition, efforts are ongoing to make internal processes as consistent and transparent as possible. The addition of the Clinical Trials e-manual to the OCT Health Canada Web site in 2006 has had a positive effect in communicating our processes to stakeholders and decreasing the number of contacts for information and number of deficiencies being identified in screening.
  
  
• Other accomplishments include the posting of two guidance documents for early consultation to Clinical Trial Sponsors for their comments. The guidances relate to requirements for tuberculosis screening of health volunteers and another for Type 2 Diabetes. Formal posting of the official version of the documents are expected in the summer of 2007.
  
  
• Health Canada has seen an increase in volume and complexity of incoming Clinical Investigation applications for medical devices. The maintenance of quality and current medical care depends on supporting a strong research initiative at Canadian centers of excellence. Assurance of the safety and credibility of these studies is a shared responsibility with the clinical investigators, health care institutions, research ethics boards, applicants (sponsors/ manufacturers), and the volunteer study subjects.
  
  
• With investments this year, Health Canada was able to initiate the establishment of an Investigational Testing Unit for the review of medical device investigational testing applications and to increase monitoring and surveillance in this area. Staffing efforts continue and once acquired the unit will be in a better position to address the significant increase in incoming medical device investigational testing applications (ITA), incident reports (IR) and ensure timely response and appropriate communications/linkages with pre-market reviewers and post-market surveillance areas. The workload in FY 2006 for ITAs was 118 new applications; for ITA-IRs 160 amendment applications, with authorization completed on time 92% of the time. Although the volume was similar in 2005, 307 new and amendment applications were processed with approximately 85% completed on time.

Pandemic Influenza

In 2006 the Health Portfolio received funding over five years to improve preparedness for avian and pandemic influenza.

• In 2006-07, Health Canada enhanced its regulatory review capacity by one assessment officer in the area of anti-viral drugs. The work is to develop a guidance document for the submission and expedited review of pandemic drugs. Initial drafting is underway and consultations within Health Canada are currently ongoing to ensure the proposed process would be the best path to rapidly and efficiently review drug submissions in the event of an influenza pandemic. It is expected that an internal draft will be available in the coming year.
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3. Strategic Enabler: Governance

The strategic plan will help shape the future organizational nature of TPD. TPD envisions an effective management structure that provides strategic direction, leadership and accountability through sound planning and timely decision making. There are clear priorities and clarity around roles, responsibilities, performance goals and accountability. TPD management supports and encourages a collaborative and consultative approach to workload management and problem solving.

The following activities outline progress that has been achieved during the 2006-2007 fiscal year towards Strategic Enabler: Governance.

• A 2006-2009 Strategic Plan was established for TPD. This plan helps to ensure that we are guiding the organization collectively towards the strategic plan of the branch.
  
  
• Governance issues have been identified and consultations were held with other directorates to help define best practices.
  
  
• Roles and responsibility charts have been produced for each bureau.
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4. Strategic Enabler: People

Competent people with the skills, knowledge and tools required will be crucial to TPD's successful achievement of its vision for the future.

The strong science-based capacity that has been a foundation of TPD excellence in the past will be further enhanced through human resources planning and effective training programs to ensure the right people with the right knowledge are in place at the right time. The strategic plan will help ensure that TPD has a world-class workforce dedicated to regulatory science excellence. It will also help establish and maintain TPD as a workplace of choice.

The following activities outline progress that has been made during the 2006-2007 fiscal year towards Strategic Enabler: People.

Training

TPD specific training initiatives are focused on providing TPD staff and management with the skills and training required to support the achievements of TPD's strategic and ongoing objectives.

All TPD training is customized based on a needs assessment, planned and developed to meet these needs and then delivered by industry experts to TPD staff. The customized TPD training programs managed during 2006-2007 were:

• Competency Based Management Training Program: TPD established a partnership for the project with the Biologics and Genetic Therapies Directorate in the fall of 2006. Following the competitive process in 2005-2006 to select a vendor, proceeding with the project's design and development phase was contingent on a thorough needs analysis which was completed in January 2007. The needs analysis validated that such a customized management training program for TPD and BGTD managers was needed and welcomed. The results identified the priority competency areas that would form the basis of the training program. The program is being designed in a modular format, five two-day training sessions, delivered over a period of time starting in September 2007.
  
  
• Customized Performance Discussion Process (PDP) Training Program for managers and other staff: In the spring of 2006, five 1.5 day training sessions were delivered to approximately 60 TPD managers and supervisors. Thirteen half-day information sessions were given to approximately 300 employees.
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5. Strategic Enabler: Relationship Management

Successful organizations focus attention on their relationships, both internal and external. Common understanding of roles and responsibilities as well as common and consistent behavioural approaches are key success factors. The strategic plan recognizes the importance of strong and effective relationships.

The way TPD manages its relationships with internal partners and external stakeholders, both domestically and internationally, will greatly impact the directorate's ability to achieve its commitment for regulatory modernization and performance sustainability.

As we move forward with the elements of the strategic plan, the quality and effectiveness of relationships will be improved as clearer understanding of our mutual roles and responsibilities is developed and shared.

How we interact with our colleagues and with our stakeholders are also important to cultivating and maintaining effective relationships. We need to develop a common approach to dealing and communicating with others, including people within the directorate and branch, our external stakeholders, and regulators in other jurisdictions.

The following activities outline progress that has been made during the 2006-2007 fiscal year towards Strategic Enabler: Relationship Management.

Bilateral Meeting Program

TPD hosts regular bilateral meetings with a number of national stakeholder organizations to discuss and consult on regulatory issues of mutual interest, exchange information, share expertise and, when appropriate, responsibilities. These organizations include those whose business is directly impacted by the regulation of pharmaceuticals and medical devices, e.g. industry and pharmacy associations. The Bilateral Meeting Program (BMP) supports TPD's strategic commitment to build collaborative relationships.

International Regulatory Cooperation

The International Regulatory Cooperation (IRC) Initiative involves further development to strengthen relations with other regulatory authorities and with international health organizations to provide a more effective, efficient, and informed domestic regulatory program. IRC also includes initiatives designed to improve the regulatory capacity of developing and emerging countries with a view to mitigating risks associated with products imported into Canada. IRC activities may take place within a bilateral or multilateral context, guided by a cohesive international strategy that helps ensure optimal benefit from invested resources.

TPD is engaged in a number of collaborative activities with foreign counterparts, which include information and personnel exchanges, training, participation on external and internal scientific committees and joint projects. The recent negotiation of memoranda of understanding (MOU) with other authorities, the formation of joint oversight groups, and the development of a renewed TPD International Regulatory Cooperation Strategic Framework and annual work plans all point to the strategic, outcomes-based approach being taken by TPD with regards to IRC.

The following are some of the specific achievements of the IRC initiative in 2006-2007.

• Following the completion of the HPFB IRC Strategy in February 2006, a first draft of the TPD IRC Strategic Framework was developed and presented to Senior Management in November 2006. Comments were subsequently reviewed and a second version of the draft strategy was prepared.

Cooperation with the US Food and Drug Administration (FDA)

Centre for Drug Evaluation and Research (CDER) - Pharmaceuticals:

• Productive discussions between TPD Review Bureaus and CDER Review Divisions continued throughout 2006-2007. In the 2006 calendar year, there were over 15 interactions in which discussions took place on review and post-market safety issues.
  
  
• The Pharmaceutical Science offices of the FDA and TPD continued to engage in meetings to share information and best practices, and to discuss opportunities for cooperation. Exchanges have proven valuable in identifying best practices, discussing scientific approaches, and assisting in preparing for the implementation of approaches.
  
  
• A Chemistry and Manufacturing Controls discussion forum took place in May 2006 in Rockville, Maryland, covering a variety of current topics. Interest was expressed in devoting the next forum to generic drug issues, an area identified by both the FDA and TPD as opportune for enhanced collaboration.

Centre for Devices and Radiological Health (CDRH) - Medical Devices:

• Progress towards the establishment of a Pilot Multi-purpose Audit Program (PMAP) continued. In August 2006, a notice was posted to the Health Canada Web site and sent to Auditing Organizations from both Health Canada and FDA inviting their participation in the PMAP. Separate letters were also sent by both organizations to manufacturers of medical devices. Furthermore, the drafting of a Questions and Answers document was undertaken to explain and address questions related to the PMAP.
  
  
• A two-day meeting between senior officials from HPFB and CDRH took place September 21-22, 2006 in Ottawa to discuss common challenges and to explore possible areas of cooperation across a broad range of regulatory activities.

Cooperation with Europe:

• Confidence building activities between HPFB and the European Directorate for the Quality of Medicines (EDQM) culminated in March 2007 with the signing of an MOU, led by TPD, at the opening ceremony of the new EDQM facilities in Strasbourg, France.
  
  
• The signing marked the end of Phase 1 of the project and allowed for Certificates of Suitability (CEPs) issued by the EDQM to be submitted to TPD by a drug substance manufacturer in conjunction with a complete Drug Master File (DMF), reducing the need for review of the closed portion of the DMF.
  
  
• At the same time, TPD reviewers continued to contribute to EDQM review sessions.

Cooperation with Australia:

• Work progressed on the negotiation of an MOU and the completion of a confidence building exercise between HPFB (represented by TPD) and Australia's Therapeutic Goods Administration (TGA) on the recognition of certificates for quality management systems. This would facilitate access to medical devices in the respective markets, while maintaining high regulatory standards for these products.
  
  
• In December 2006, an on-site assessment by HPFB took place at TGA headquarters in Canberra following the completion of a documentation review. Training on Canadian requirements also took place at that time.

Cooperation with China:

• Senior HPFB officials attended a productive senior officials meeting in Beijing in June 2006, where a signing took place to renew the Plan of Action between HPFB and The State Food and Drug Administration (SFDA), for continued regulatory cooperation in the area of therapeutic products. The meeting also allowed for the identification of new work items for both pharmaceuticals and medical devices. Officials agreed to hold the next meeting in Ottawa in the spring of 2007.
  
  
• Key activities that took place in 2006-2007 included: A three-week study tour that was organized for the SFDA and BDA (Beijing Drug Administration) on the review and approval of IVDD; the hosting of a delegation from the Shanghai Municipal FDA to provide an overview of pre-market review and post-market surveillance; and the delivery of a three-day workshop by a TPD medical devices expert in China. The workshop focused on medical devices regulation and clinical trials of high risk medical devices. More than 90 SFDA staff participated in the workshop.

New MOUs signed with Singapore and Swissmedic:

• In the fall of 2006, senior officials meetings were held and MOUs signed in Ottawa between Singapore's Health Sciences Authority (HSA) and Switzerland's Swissmedic, similar to the broad information-sharing MOUs previously signed with the US FDA and Australian TGA. Areas of cooperation and draft implementation plans were also discussed.
  
  
• These arrangements are expected to promote enhanced bilateral and multilateral cooperation and establish a regulatory network of like-minded regulatory authorities. Annual meetings of senior officials are to be convened with MOU partners to establish workplans and assess the outcomes of cooperative efforts.

Cooperation with Other Countries:

• TPD continues to receive a significant number of requests from countries with developing regulatory systems, with the objective of learning best practices and exploring the potential for future cooperation. During FY 06-07, TPD received close to 15 visiting delegations, including a two-week visit by the Uganda National Drug Authority and a visit by Ukrainian HIV laboratory specialists. In order to maintain a high level of efficiency and excellence in providing training programs, TPD has identified as a priority for the upcoming year the development of an International Training Strategy.

International Harmonization

The International Harmonization Initiative refers to the development, adoption, and implementation of international technical standards for the development, registration, and control of pharmaceuticals and medical devices. Harmonization may also extend to the convergence of regula-tory practices and processes.

International Conference on Harmonisation

ICH Participation:

Over the last fiscal year, TPD continued to actively participate in all ICH-related activities, including expert working groups involved in the development of international guidances, as observer to the ICH Steering Committee (SC), and as regulatory co-chair of the Global Cooperation Group.

Notable developments included:

• The decision to collaborate with accredited Standards Development Organizations to leverage the development of technical standards for ICH e-Initiatives. Pilot to involve E2B (Individual Case Safety Reports) and M5 (Medicinal Product Identifier).
  
  
• Identification of safety guidelines in need of revision in order to keep pace with evolving science and to reduce, refine and replace animal testing, whenever possible.
  
  
• Continuation of initiatives to improve the transparency, openness and efficiency of ICH operations.
  
  
• Discussions on defining a strategic vision for Quality topics.
  
  
• Endorsement of a global training and capacity building strategy.
  
  
• Endorsement of new topics and draft guidelines.

ICH Action Plans/Delivery (topic specific):

Adoption of new topics:

• Development Safety Update Reports (E2F) will harmonize requirements for annual clinical trial reporting in the three regions.

Maintenance of existing Safety guidelines:

• Carcinogenicity (S1C), Genotoxicity (S2A/B), and the Timing of Nonclinical Studies (M3).

Guidelines expected to reach draft for consultation (Step 2):

• Development and consultation on new draft guidelines: Pharmacogenomics (E15) describes harmonized terminology for use in regulatory documentation and establishes a basis for further harmonization.
  
  
• Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (Q4B). The former defines the process for regulatory acceptance of harmonized monographs among US Pharmacopoeia, European Pharmacopoeia, and Japanese Pharmacopoeia.
  
  
• Gene Therapy Discussion Group finalized its Considerations Document on Inadvertent Germline Transmission.

Pan American Harmonization Initiatives:

• TPD continues to participate in Pan American activities that promote convergence of systems and standards in order to promote the quality, safety and efficacy of therapeutic products in the Americas. This includes coordinated activities for medical devices and drugs, the latter of which is coordinated through the Pan American Network on Drug Regulatory Harmonization (PANDRH).
  
  
• TPD, representing Health Canada, participated in a crucial SC meeting in Washington, June 26-28, 2006. This meeting was funded by Canada-PAHO with the goal of taking a strategic view of PANDRH and determining how best to improve operations and harmonization outcomes. HPFB helped prepare a discussion document for this purpose and lead SC discussions.
  
  
• TPD also participated in a Bioequivalence working group meeting May 22-24, 2006 in Uruguay to further develop an implementation strategy for Bioequivalence studies for generic products, an important regulatory issue within the Americas.
  
  
• TPD participated in an APEC-sponsored workshop of the Global Harmonization Task Force (GHTF) in Santiago, Chile, May 9-12, 2006 in an effort to promote awareness of GHTF guidances and approaches within Latin America. The meeting also allowed for preliminary discussions on addressing the needs of regulators of medical devices within the Americas and Caribbean through a multi-country training program, with the support of PAHO.

International Pharmacopoeias & Standard Setting:

• TPD continued to participate in expert committees involved in standard setting and drug information, as well as holding membership in the US Pharmacopoeia Convention.
  
  
• HPFB continued to send two observers to the meetings of the European Pharmacopoeia Commission, one from BGTD (lead and biologics) and one from TPD (pharmaceuticals).

Attendance at these sessions (March, June, and November) allowed for Canadian input during the priority setting agenda for inclusion of monographs in the European Pharmacopoeia.

• In addition, TPD participated in the opening and closing plenary sessions of the International Conference on New Frontiers in the Quality of Medicines in Strasbourg, France, June 13-15, 2007. This conference was sponsored by the European Directorate for the Quality of Medicines and Healthcare (EDQM), with the objectives of fostering international dialogue and strengthening cooperation in the setting of standards on the quality of medicines. Health Canada continues to play an important role in contributing to these standards, both through direct relationships with pharmacopoeia such as the European Pharmacopoeia of EDQM and through multilateral initiatives such as the International Conference on Harmonisation.

Communications

Communications involves an array of communication products and events to inform internal staff and stakeholders of our corporate priorities, mission, vision, success stories and current issues. These include the TPD news, kit folders, brochures and events such as all-staff meetings, BMP (Bilateral Meeting Program) meetings and ACM (Advisory Committee on Management) meetings. All of these are key in allowing us to communicate both achievements and items of interest to all staff and key stakeholders.

Communication Products:

• TPD News: TPD continues to produce a quarterly newsletter to communicate items of interest to staff and key activities and progress. Over the course of the last fiscal year, four issues were produced (summer 2006, fall 2006, winter 2006 and spring 2007) which were distributed in electronic format to all TPD staff and key external stakeholders.
  
  
• Kit Folders: New kit folders were produced that include updated Vision and Mission statements, and photos.
  
  
• Brochures: More copies of the "What is the Therapeutic Products Directorate?" brochure were printed.

Communication Events:

• All Staff Meetings: One all-staff meeting was held on September 27, 2006. The meeting provided a short update on TPD's corporate priorities and was followed by an awards and recognition ceremony.
  
  
• HPFB Advisory Committee on Management Meeting (ACM): TPD/OBT provided logistical support for an ACM. The meeting was held June 15-16, 2006 and covered the following topics:
  
  
  • Comprehensive Review Vision Paper.
  • Therapeutic Effectiveness.
  • Progressive Licensing Framework.
  • Special Access Program Review.
  • Policy on Public Involvement in the Review Process.

Future Plans For 2007-2008

1. Strategic Objective: Modern Regulatory Framework

PROGRESSIVE LICENSING PROJECT

• An analysis of the feedback and input obtained to date will be completed fall 2007.
  
  
• A vision document will be published that will outline Progressive Licensing in more detail.
  
  
• Ongoing stakeholder engagement will continue through meetings and electronic consultations.
  
  
• A work plan will be developed for the implementation of Progressive Licensing, including regulatory and guideline development.
  
  
• A change management strategy will be created for internal and external stakeholders.

SCHEDULE A

• In June 2007, TPD will seek Treasury Board approval for Project 1539 prepublication in Canada Gazette, Part I (CG I).
  
  
• Stakeholders will be informed by direct email and web posting on the Health Canada Web site.
  
  
• Internal and external consultation on Project 1539 will be held during the CG I 75-day comment period starting June 18, 2007.

CLINICAL TRIAL REGISTRATION AND DISCLOSURE

• The first draft of Issue Analysis Summary with recommendations for implementation will be prepared.
  
  
• The recommended option for registration will be approved.
  
  
• First phase of implementation to begin spring/summer 2007 (begin preparation of regulatory package for CGI; request voluntary registration in the interim).
  
  
• Communications will be issued to stakeholders to inform/educate about regulatory requirements being developed and encourage voluntary registration in the interim.
  
  
• A project plan for the creation of a Canadian search portal will be developed.
  
  
• We will continue to monitor and, where appropriate, participate in the numerous registration and disclosure initiatives that are underway worldwide.
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2. Strategic Objective: Performance Sustainability

REVIEW PERFORMANCE

• TPD's goal is to continue to achieve and sustain 90% review on time during fiscal 2007-2008 for all new drug and generic drug submissions as well as class II, III and IV medical device applications.

PROJECT/WORKLOAD MANAGEMENT

• For 2007-2008, workload reports will be produced monthly and all workload management forum meetings and presentations to TPD management committee will be held on a monthly basis.
  
  
• A draft Master SOP for pre-submission meetings has been developed and is currently in the internal comment stage. In parallel, in FY 2007-2008, we will endeavour to develop a document outlining the best practices for pre-submission meetings and other submission- related industry and TPD meetings. A presentation of the best practise for pre-submission meetings from a TPD perspective will be presented to the Canadian Association of Professional Regulatory Affairs in the fall of 2007; at which time, informal external consultation and comments can be obtained.
  
  
• Continuous liaising with the Office of Clinical Trials has been established in order to strengthen and improve communication between the clinical development (i.e., clinical trials) and pre-market (drug review) stage of a drugs life cycle.
  
  
• The program co-led a pilot project with the Common Drug Review (CDR) to establish earlier interactions between TPD and CDR which would in turn facilitate information sharing, and ultimately earlier access to medicines. This networking enabled the TPD and CDR to develop a preliminary drug review process guideline.
  
  
• In FY 07-08, emphasis will be placed on improved and consistent project management-related processes, such as: internal filing meetings, facilitation between the pre-market review divisions and Summary Basis of Decision, on an ongoing basis.
  
  
• Approximately six more master SOPs are in development or will be initiated during the upcoming year. Each SOP category will result in the creation of further sub-SOPs based on the RPMD needs assessment.

GOOD GUIDANCE PRACTICES

• The final GGP Manual will be posted to the Health Canada Web site in the first half of 07/08.
  
  
• Guidance coordination capacity needs to be established and will take place in 2007/08. This will include the continued development of a guidance inventory, maintained needs assessment and liaison with other bureaus within TPD. The GGP coordination unit will also seek to develop a guidance plan which will be subject to changing priorities and resource limitations. The reliability of such a plan will only be assessed after a number of years once trends are evident.
  
  
• The Bureau of Policy Science and International Programs (BPSIP) will continue to provide guidance development advice, consistent with GGP, on an ad-hoc basis to other areas of the program.
  
  
• BPSIP will undertake an exercise in 2007/08 to extend development of an existing inventory to include guidance development activities underway in all TPD bureaus.
  
  
• Although the guidance needs assessment has already been completed, the list will require updating on a regular basis to reflect changing priorities, expectations and resourcing.
  
  
• Additional resourcing will be pursued to meet the requirements needed for GGP implementation.

GOOD REVIEW PRACTICES

• A SOP on preparing review reports for Periodic Safety Update Reports (PSURs) for products authorized under the Notice of Compliance with Conditions policy will be released
  
  
• A SOP on orientation of new drug and device reviewers in TPD will be released.

ENHANCED REVIEW CAPACITY

Scientific Advisory Bodies

Standing Committees:

• One meeting will be held in early June and one is proposed for November 2007 for the Scientific Advisory Committee on Medical Devices used in Cardiovascular Systems (SAC-MDUCS).
  
  
• Two meetings are scheduled for September 13, 2007 and March 2008 for the Scientific Advisory Committee on Oncology Therapies (SAC-OT).
  
  
• One teleconference is scheduled for June 26, 2007 for the Scientific Advisory Committee on Anti-Infective Therapies (SAC-AIT).
  
  
• One teleconference is scheduled for September 4, 2007 for the Scientific Advisory Committee on HIV-Therapies (SAC-HIV-T).
  
  
• One meeting is proposed for winter 2008 of the Scientific Advisory Committee on Human Reproductive Therapies (SAC-HRT).
  
  
• One meeting is scheduled for November 15, 2007 for the Scientific Advisory Committee on Metabolic and Endocrine Therapies (SAC-MET).
  
  
• One two-day meeting is scheduled for October 2 & 3, 2007 for the Scientific Advisory Committee on Respiratory and Allergy Therapies (SAC-RAT).

Advisory Panels:

• Four to six panels are usually developed each fiscal year, on an "as-needed basis." Therefore, subjects/titles cannot be predicted.

Enhanced Contracting Capacity

• Following a comprehensive demonstration, the Scientific Experts Database will be launched and deployed.
  
  
• User/admin training manuals finalized and translated.
  
  
• Our marketing brochure will continue to be mailed out to interested parties/potential applicants.
  
  
• The targeted outreach strategy will be further developed.
  
  
• Statistics will be tracked and reported regarding database usage and functionality.
  
  
• Environmental scans and attendance at workshops/conferences, etc will continue.
  
  
• Phase 3 enhancements to database will be developed as required.

SUMMARY BASIS OF DECISION

• Phase I implementation will continue in 07/08. The SBD unit will continue to work with TPD and BGTD staff and managers to improve implementation. Revised templates and SOPs will be posted on the Health Canada Web site for information.
  
  
  
• Evaluation of phase I is anticipated to begin in Q4 of 2007/2008 and will include an evaluation of infrastructure, anticipated submissions, resource requirements and feedback received on Phase I of the initiative. Evaluation methods to solicit critical feedback from affected stakeholders (on Phase I) will be explored and initiated as appropriate. The evaluation of phase I will also contribute to the action plan for phase II implementation in 2008/2009.

PRODUCT MONOGRAPH

• An evaluation of the product monographs submitted in the new format is ongoing. The Product Monograph Working Group is currently developing an implementation strategy to ensure that PMs for all submission types (where appropriate) will transition to the new format and requirements in an acceptable time period. Target date for implementation is Winter/Spring 2007-08.
  
  
• External consultation on HC proposals related to Public Availability of PMs, in the form of a Notice to stakeholders, will be posted to the Health Canada Web site in summer 2007. The target date for Product Monograph posting to the Health Canada Web site is winter 07/08. Implementation particulars will depend in part on results of the external consultation.

E-REVIEW

• The long-term viewing tool (docuBridge) will be released in a production environment. This will include:
  
  
  • A completed Threat Risk Assessment (TRA).
  • A developed Hosting Agreement with IMSD.
  • docuBridge installed on Citrix MetaFrame to support teleworkers.
  • Requirements developed for enhancement to docuBridge.
  • Complete installation of Adobe Acrobat Professional Version 7 for all review staff.
  • Tested and implemented enhancements to docuBridge.
  • Standard Operating Procedures.
    
    
• iSubmit will be implemented to enable docuBridge for the management and review of the electronic documents filed in conjunction with the paper submissions (non eCTD format). SOPs will also be developed.
  
  
• Training will be provided to all review staff in TPD and BGTD for docuBridge, Adobe Acrobat, and for working with the eCTD format.
  
  
• Enhancement to the eCTD validator will be tested and validated.
  
  
• eCTD format submissions for TPD and BGTD will be validated and registered.
  
  
• An assessment of the hybrid filling format pilot will be performed.
  
  
• The eCTD validation rules will be published and continuously enhanced.
  
  
• Standard operating procedures and guidance documents related to submissions in electronic format will be updated.
  
  
• The interim viewing tool for eCTD paper/electronic co-submission and Hybrid filing formats will continue to be supported until such date that docuBridge is in place in the Citrix MetaFrame environment to support access to submission in eCTD format to teleworkers.
  
  
• A tool to support the Special Access Program will be evaluated, selected and acquired through a procurement process.
  
  
• The Canada Vigilance system will be configured for the handling of Clinical Trials Adverse Drug Reaction and implemented.

SPECIAL ACCESS PROGRAM

• A guidance document for SAP will be developed and reach policy step 5 (solution implementation).
  
  
• Regulatory amendments to permit block release of non-marketed drug will be pre-published in CGI, and ultimately published in CGII.

SAP Operational Review:

• Delivery of the SAP Operational Review final report and recommendations will be completed in April 2007.

SAP Ethics Review:

• A workshop with the contractors and key Health Canada personnel will be held to launch the project.
  
  
• The first draft discussion paper will be delivered during the summer of 2007 for review.
  
  
• Delivery of the final discussion paper is expected during fall of 2007.
  
  
• An external expert panel will be convened during winter 2007-2008 to peer review the discussion paper.

SAP Broad Policy/ Regulatory Review:

• A comprehensive evaluation of SAP, including external consultation to reach policy step 3 (solution development) will commence. The comprehensive evaluation will involve the following:

Issues will be identified with the SAP:

• Several bilats will be held with stakeholders.
  
  
• Phase I: consultations will consist of two Issue-framing sessions in June 2007, with key stakeholders including practitioners, patient groups and veterinarians:
  • Vancouver Issue-Framing Sessions.
  • Ottawa Issue-Framing Session.
    
    
• An Issue Identification Paper will be developed from information gathered in Phase I consultations.
  
  
• Phase II: E-consultation- the Issue Identification Paper will be validated through Web posting.
  
  
• An Issue Analysis with Options will be developed following Phase II E-consultation to address problems and provide recommendations with the SAP.
  
  
• Phase III: Public Form consultation regarding options and recommendations will be held.

CLINICAL TRIAL/INVESTIGATIONAL TESTING

Clinical Trials:

• Clinical and quality components of clinical trial applications, amendments and notifications will continue to be reviewed and evaluated.
  
  
• Pre-clinical trial application meetings will be held.
  
  
• Clinical trial adverse drug reactions will continue to be assessed.
  
  
• Work will begin towards implementation of the Canada Vigilance System in the ADR division to improve TPD's capacities to carry out pre-market safety surveillance.
  
  
• Scientific advice and interpretation on drug issues related to clinical trials will continue to be provided.
  
  
• We will continue to respond to enquires from clinical trials sponsors, qualified investigators and others involved in the conduct of clinical trials.
  
  
• Incoming applications will be screened for compliance with established regulations, policies and guidances.
  
  
• Align scientific expertise of staff to mirror increase CTA workload in specific clinical areas (i.e., oncology, infectious disease etc).
  
  
• The Office of Clinical Trials (OCT) will continue to be involved in numerous working groups and initiatives to gain efficiencies in the review process including the five year evaluation of Division 5 of the Food and Drug Regulations.

Investigational Testing:

• An evaluation and issue authorization will be conducted for clinical investigation in a controlled fashion of devices not licensed for general sale in Canada to assess their safety and effectiveness.
  
  
• Regulatory amendments.
  
  
• A revised Investigational Testing Guidance Document will be prepared (depending on available resources).
  
  
• Bureau presentations are to be delivered at industry and professional meetings and workshops.

PANDEMIC

• An internal draft guidance document for the submission and expedited review of pandemic drugs will be available in the coming year.
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3. Strategic Enabler: Governance

• TPD will aim to work collectively towards improving our strategic direction and corporate decision making.
  
  
• TPD will work to improve planning and accountability.
  
  
• TPD will work to identify and mitigate risks and gaps in our business.
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4. Strategic Enabler: People

TRAINING:

Competency-based Management Training Program (CBMTP)

• Customized training materials for the five modules will be drafted.
  
  
• The CBMTP advisory group will provide feedback on the draft modules.
  
  
• Project updates will be communicated to staff and management.
  
  
• Draft training modules will be pilot tested.
  
  
• Training materials will be finalized and translated.
  
  
• The training program will be delivered from September 2007 until May 2008 to 100 TPD and BGTD managers.
  
  
• Evaluations will be conducted.
  
  
• Coaching and mentoring will be available to participants throughout the program.
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5. Strategic Enabler: Relationship Management

BILATERAL MEETING PROGRAM

• The Bilateral Meeting Program will continue to host regular bi-lateral meetings with twelve national stakeholder organizations.

INTERNATIONAL REGULATORY COOPERATION

• TPD's IRC strategy will be finalized and a management process for the annual review of priorities will be developed.
  
  
• Contributions to HPFB-led efforts will include:
  
  
  • Activities related to import safety under the Security and Prosperity Partnership (SPP), Trilaterals (Canada-Mexico-US) and other initiatives.
  • Confirmation of areas of cooperation with MOU partners.
    
    
• Training will continue to be delivered as needed within TPD, on good inter-agency practices regarding communication and confidentiality issues stemming from the signing of MOUs.
  
  
• Where possible, TPD will continue to respond to visit requests from countries with developing regulatory systems.
  
  
• At the same time, an International Training Strategy for TPD will be developed to make best use of directorate resources in responding to capacity building requests received from developing and emerging countries.
  
  
• A framework for personnel exchanges between TPD and other countries will be developed and endorsement will be pursued.
  
  
• Support will be provided to the WHO in their efforts to recruit a TPD Clinical Assessor for a one-year assignment.

Cooperation with the US FDA

• Work will continue towards achieving concrete deliverables, building upon successful exchanges of information, best practices, and a desire to achieve meaningful outcomes in selected areas of mutual interest, including generic drug review and the PMAP.

Cooperation with EDQM

• Phase 2 of the EDQM project will be assessed with a view to provide a new filing option and a more efficient review process in Phase 3. Contributions will be made on the EDQM's CEP review process.

Cooperation with TGA

• The HPFB-TGA MOU on Quality Management Systems will be finalized and signed. The signing ceremony is scheduled for June 1, 2007 at TGA Headquarters in Canberra. Work will continue towards the completion of the confidence building exercise, operationalizing the arrangement.

Cooperation with SFDA

• Plans will be made for the next HPFB-SFDA senior officials meeting to take place in Ottawa. Progress will continue to be made on priorities agreed to in the Plan of Action.
  
  
• A joint training program will be explored with a Chinese university to complement existing efforts with the SFDA to promote the use of international approaches and standards to serve as a pilot for the branch.

Cooperation with HSA and Swissmedic

• Workplans for cooperation will be finalized and contributions will be made to senior officials' discussions.

INTERNATIONAL HARMONIZATION:

International Pharmacopoeias & Standard Setting

ICH Participation:

HPFB will continue to participate in all ICH related activities in the next fiscal year including on expert working groups involved in the development of international guidances, as observer to the ICH Steering Committee, and as regulatory co-chair of the Global Cooperation Group (GCG). The next meetings will take place in Yokohama in October 2007; and subsequent meetings in USA and Europe in 2008, dates and locations to be determined.

Notable plans include:

• Further collaboration with accredited Standards Development Organizations to leverage the development of technical standards for ICH e-Initiatives.
  
  
• Continuation of initiatives to improve the transparency, openness, and efficiency of ICH operations.
  
  
• Development of a strategic vision for Quality topics.
  
  
• Continuation of progress by the GCG on promoting better understanding and use of ICH guidelines beyond ICH regions.
  
  
• Development of new topics and draft guidelines (see below).

ICH Action Plans/Delivery (topic specific)

Adoption of new topics:

• Oncology Therapeutics (S9).
  
  
• The Steering Committee is expected to adopt a proposal from the Gene Therapy Expert Group to hold a workshop on Viral Shedding in the margins of the European Society for Gene Therapy annual meeting in Rotterdam, fall 2007.
  
  
• Other topics: to be confirmed.

Guidelines expected to reach draft for consultation (Step 2):

• Pharmaceutical Quality Systems (Q10) reached step 2 (draft for consultation).
  
  
• Development Safety Update Reports (E2F) expected to reach Step 2.
  
  
• Safety guidelines S2, M3 expected to reach Step 2.

Guidelines expected to reach completion (Step 4):

• Pharmacogenomics (E15).
  
  
• Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (Q4B):
  Core guideline and 1-2 annexes.

Pan American Harmonization Initiatives

• In the next fiscal year, HPFB will continue to participate in Pan American activities that promote convergence of systems and standards in order to promote the quality, safety and efficacy of therapeutic products in the Americas.
  
  
• The next Steering Committee meeting (SC) is to take place in the fall 2007, at which time a review of current problems and proposed solutions will be examined as part of the strategic review of Pan American Network on Drug Regulatory Harmonization (PANDRH) activities. The SC will also undertake planning for the next conference, now targeted for the first semester of 2008. The Bioequivalence (BE) Working Group is also expected to meet to finalize the implementation strategy for BE studies, an important PANDRH deliverable.

International Pharmacopoeias & Standard Setting

• Ongoing work with other international groups of experts involved in setting standards, test methods and drug information will continue.
  
  
• TPD will continue participating in US Pharmacopoeia (USP) and its working groups. The 2007 USP Annual Scientific Meeting is scheduled for September 25-27, 2007.
  
  
• HPFB will continue to participate in meetings of the European Pharmacopoeia Commission and its working groups in the upcoming fiscal year. The next session will take place in November 2007.

COMMUNICATIONS

Communications Products

• TPD News will continue to be produced quarterly.