Therapeutic Products Directorate Annual Report 2007-2008

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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 Legislative and Regulatory Framework
     • Product Lifecycle Approach (Progressive Licensing Project)
     • Schedule A
     • Schedule F
     • Clinical Trial Registration and Disclosure
     • Paperwork Burden Reduction Initiative
  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 Programme
     • Clinical Trials/ Investigational Testing
     • Expedited Pandemic Influenza Drug Review (EPIDR)
  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 2008-2009
  1. Strategic Objective: Modern Legislative and Regulatory Framework
     • Product Lifecycle Approach (Progressive Licensing Project)
     • Schedule A
     • Schedule F
     • Clinical Trial Registration and Disclosure
     • Notice of Compliance with Conditions (NOCc) Policy
     • Paperwork Burden Reduction Initiative
  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 Programme
     • Clinical Trial/Investigational Testing
     • Expedited Pandemic Influenza Drug Review (EPIDR)
  3. Strategic Enabler: Governance
  4. Strategic Enabler: People
     • Training
  5. Strategic Enabler: Relationship Management
     • Bilateral Meeting Program
     • International Regulatory Cooperation
     • International Harmonization
     • Communications

Message from the Director General

I am pleased to present the Therapeutic Products Directorate's (TPD) second Annual Progress Report, which outlines our progress and accomplishments over the 2007-2008 fiscal year in support of our strategic plan. 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 2007-2008 TPD Annual Progress Report and welcome you to join in our successes.

Supriya Sharma

What We Do

The 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)
• 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; and
• Monitor and review health product safety and effectiveness information as it becomes available to ensure the benefit/risk balance remains acceptable.

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
• Litigation Support and Document Management Services

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, the European Medicines Agency 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.

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 Health Products and Food Branch (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 Legislative and 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 Legislative and Regulatory Framework

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

A modern legislative and regulatory framework, in addition to providing improved access to therapeutic products for Canadians, will help provide the flexibility needed to respond to today's needs and be adaptable to future needs. A modern legislative and regulatory framework will support needed access to promising new therapies and technology while continuously and proactively 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 2007-2008 fiscal year towards Strategic Objective: Modern Legislative and Regulatory Framework.

Product Lifecycle Approach (Progressive Licensing Project)

The Product Lifecycle Approach (PLA), formerly known as 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 PLA, Health Canada is developing a modern therapeutic product licensing framework consisting of laws, regulations and guidelines that will support timely access to products and provide mechanisms for the continuous monitoring and reassessment of a product's safety, quality and effectiveness throughout its life cycle.

The PLA conducted multiple stakeholder consultations including a five-day mock regulatory framework exercise workshop and a workshop with health care professionals. This initiative continues to engage with stakeholders which allows for evidence-based policy development to guide the modernization of the regulatory framework for therapeutic products. The result of the work done by PLA was instrumental in the drafting and introduction of proposed legislation which would have supported a life-cycle approach to the regulation of therapeutic products.

Schedule A

Schedule A to the Food and Drugs Act is a list of diseases (for example [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 1539, a regulatory amendment to revise Schedule A and to permit authorized preventative Schedule A claims for natural health products and non-prescription drugs, was pre-published in Canada Gazette, Part I, on June 16, 2007, with a 75-day consultation period.
• Project 1539 was published in Canada Gazette, Part II on December 26, 2007, (and came into force on June 1, 2008).

Schedule F

Regulatory amendments to Schedule F are an ongoing activity. For 2007-2008, 22 substances were added to Schedule F (prescription status) to the Food and Drug Regulations and three substances were switched from prescription to non-prescription status.

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.

While it explores a regulatory amendment, Health Canada is encouraging sponsors to register their trials on one of two public, international registries that can be searched free of charge. As of March 2008, over 4,500 Canadian clinical trials have already been voluntarily registered. Health Canada is working on various options to create a Canadian portal to the existing clinical trial registries to make it easier for sponsors to register, and for Canadians to search for information in both official languages. Making clinical trial information publicly accessible in registries will enhance the transparency and make the information more accessible to patients, physicians, researchers and other interested stakeholders. This in turn will allow the public to access information that is necessary to make informed choices.

Activities in 2007-08

• 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.
• Received and posted the External Working Group's Final Report with recommendations to Health Canada on how to proceed with the registration and disclosure of clinical trial information in Canada.
• Developed a draft Issue Analysis Summary outlining the issues, analysis and recommended option for implementation.
• Posted a Notice on the Health Canada website in November 2007 to clarify current position on registration and disclosure of clinical trial information, and encourage sponsors to register on one of two publicly accessible registries.
• Prepared request for new authorities under Bill C-51 in fall, 2007.
• Developed business requirements for a clinical trial registry search portal in March, 2008.

Paperwork Burden Reduction Initiative

In September 2007, a baseline count of TPD's requirements on business was determined through an exhaustive review of the directorate's relevant statutes, regulations, policies, forms and templates. The final objective of this initiative is for the department to reduce the burden of the number of requirements placed on businesses by a minimum of 20 per cent.

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 2007-2008 fiscal year towards Strategic Objective: Performance Sustainability.

Performance Review

Using funding received in Budget 2003 under the Therapeutic Access Strategy, a five-year initiative, TPD continued to reduce submission backlog and meet international review standards for new pharmaceutical and biologic drug submissions.

Drugs

Ninety-four per cent of pharmaceuticals and generic drug submissions were reviewed within the published service standards, exceeding our target of 90 per cent. For pharmaceuticals (Brand Name) and generic drug submissions, 95 per cent of 515 submission reviews were on time according to approved service standards, exceeding our target of 90 per cent. For Special Access of drugs, 99 per cent of more than 35,000 requests were assessed and responded to within the 24-hour service standard.

Medical devices

The review performance for Medical Device Class II, III, IV type applications was as follows: 70 per cent of 4,428 decisions were made within target for Class II applications, 74 per cent of 351 decisions for Private Label applications (Class II, III, and IV), 86 per cent of 1732 decisions for Class III applications, and 59 per cent of 500 decisions for Class IV applications. Therefore we have not met our target of making 90 per cent of Class II, III, IV medical device decisions on time, as only 73 per cent of 7011 decisions for the combination of all applications were made within target. The decrease in the review performance was due to the variability of medical device application monthly volumes, incremental growth in application volume, and the complexity of reviews involving emerging technologies.

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, pharmaceutical drug 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. In addition, the Regulatory Project Manager is continually aware of 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 (DSTS) 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 to TPD's success in surpassing the goal of 90 per cent review performance on time; the directorate's overall review performance for fiscal year 2007-2008 was 94 per cent for all New (and Abbreviated) Drug Submissions and Supplements. New Regulatory Project Manager (RPM) positions were filled to address submission management needs and ensure continual project management support to the Review Divisions.

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. This was also reflected in an increase in the number of pre-submission meetings requested and held between sponsors and the TPD.

One of the key aims of regulatory project management is to create a review plan for each submission that is received. This is an ongoing activity which has gained support from each of the review bureau management teams. As part of review planning, realistic milestones are defined and review team members are identified up front.

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. Further training on WBS was held for RPMD staff.

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. Training materials were developed to help standardize and improve consistency in the training of new RPM staff. Furthermore, topic-focussed sessions for staff as presented by subject matter experts were planned throughout the year and continue to be held, as a refresher for staff and to introduce new staff to the topics at hand.

Work on Standard Operating Procedure (SOP) development continues. A development plan for the RPM SOPs was created and similarly, this will be done for the Submission Coordinator SOPs. The development of SOPs is an ongoing activity that will continue throughout the next fiscal year.

Workload Management

In support of meeting review performance, the Workload Management Project continued to investigate future submission pipeline trends so that workload was better anticipated. RPMs continued to support the review process and the commitment to review submissions within performance targets.

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 RPMs in a full discussion of the new drug submission, Notifiable Change (NC) and Drug Identification Number (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:

• Number of Workload Management Forums held in 2007-08: 11
• Number of Workload Reports prepared in 2007-08: 23

TPD Management Committee (MC) Meetings

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

• No. of Submission Workload presentations to TPD-MC in 2007-08: 11.

Good Guidance Practices

Good Guidance Practices (GGPs) are the definitions, procedures and practices for the development, issuance and use of the various documents that provide guidance to staff and stakeholders of the TPD and the Biologics and Genetic Therapies Directorate (BGTD).

In 2007-2008 efforts focused on implementing the GGP Initiative. This included finalization of the GGP manual, developing an inventory of TPD guidance both completed and under development, creation of documentation nomenclature in line with records management practices, providing continued advice on the development of new guidance, acting as primary liaison to senior management, branch staff and external stakeholders on GGP issues, and starting to draft standard operating procedures to introduce consistency and transparency into GGP practices.

Good Review Practices

The Good Review Practices (GRP) Initiative was undertaken to create a coordinated approach to the development of all review standards. GRP 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 GRP project continued supporting the review process with appropriate and enhanced review guidance, procedures and templates. Progress was challenging as the work requires an investment in time and effort from review staff whose first priority is review performance. Utilizing limited review resources, progress was made with regard to the Reviewer Orientation Program Framework. For example, an SOP on Orientation of New Drug and Device Reviewers was released and the first of many orientation courses to be developed and delivered is underway. (An orientation course on the regulatory framework on drugs and devices.)

An SOP on Periodic Safety Update Reports for Products Authorized under the Notice of Compliance with Conditions Policy was released in fiscal year 07-08. This SOP increases the consistency of reports prepared by TPD reviewers.

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 fiscal year 07-08:

Scientific Advisory Committees

• One meeting was held for the Scientific Advisory Committee on Respiratory and Allergy Therapies (SAC-RAT).
• Two meetings were held for the Scientific Advisory Committee on Medical Devices used in Cardiovascular Systems (SAC-MDUCS).
• One meeting was held for the Scientific Advisory Committee on Oncology Therapies (SAC-OT).
• One meeting was held for the Scientific Advisory Committee on Metabolic and Endocrine Therapies (SAC-MET).
• One meeting was held for the Scientific Advisory Committee on Human Reproductive Therapies (SAC-HRT).
• One teleconference and one email survey were held for the Scientific Advisory Committee on HIV-Therapies (SAC-HIV-T).
• One teleconference was held for the Scientific Advisory Committee on Anti-Infective Therapies (SAC-AIT).

Scientific Advisory Panels

• One meeting was held for the Scientific Advisory Panel on Non-Prescription Paediatric Cough and Cold Medications (SAP-NPCCM).

In relation to the Enhanced Review Contracting Capacity

• The Scientific Experts Database (SED) was launched and deployed to TPD Users;
• Other directorates within the branch showed an interest in the SED and use of ERCU's contracting services. Presentations were made to those interested and other directorates such as BGTD, Natural Health Products Directorate (NHPD), Marketed Health Products Directorate (MHPD) and Food Directorate (FD) are participating in this initiative.
• User/admin training manuals were finalized and translated.
• Phase 2 enhancements to database were developed as required and we continued to work closely with our Information Technology (IT) team to update the database.
• Deployment to other SED users outside of TPD was started.
• A new contracting process to be used with other directorates was drafted and reviewed.

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 SBD document outlines the scientific and benefit/risk based considerations 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.

Notices of Decision (NDs) and SBDs are drafted for authorized new drug submissions (NDS) for a new active substance (NAS) and for a sub-set of authorized class IV medical device applications.

Summary Basis of Decision Implementation

• Subsequent to Phase I implementation in January 2005, SBDs continued to be drafted and published throughout fiscal year 07-08 for NAS NDSs and a subset of Class IV medical device applications. During fiscal 2007-2008, 32 ND and 29 SBD documents were published for pharmaceuticals, biologics, and medical devices.

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. The Product Monograph Guidance, outlining the revised format requirements, became effective on October 1, 2004.

Revised Product Monograph Implementation:

• On May 29, 2006, a Notice to Stakeholders was posted to the Health Canada website with information pertaining to a revision of the implementation of the Product Monograph Guidance. Flexibility was introduced, making the requirement to file in the new format applicable only to NDS and Abbreviated New Drug Submissions (ANDS) or Supplemental Abbreviated New Drug Submissions (SANDS) where the innovator was already in the new format.

Dissemination of the Product Monograph- Public Availability:

• 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 undertook a plan to make product monographs publicly available and this intent was communicated through a series of notices, the most recent of which is dated September 7, 2007.
• Making Product Monographs available to the public is aligned with the department's commitment to enhance openness and transparency and responds to demands from health professionals, other Canadian regulatory bodies, agencies, patients and consumer groups, for greater access to Health Canada authorized drug product information.
• Market notified Product Monographs authorized subsequent to January 2004 became available on the department website through the Drug Products Database (DPD) on February 4, 2008.
• Procedures for submitting translated product monographs were also posted in February, 2008.
• Product Monograph availability was a commitment noted at a multi-jurisdictional stakeholder meeting convened by Health Canada in April 2007, to discuss Consumer Information and the potential for discrepancies between Health Canada authorized consumer information and that provided by pharmacies at point of sale.
• As the majority of drug submissions with their accompanying product monograph are written in English, the majority of product monographs initially in the departmental database are in only one official language, that is [e.g.], English. Health Canada recognizes the importance of bilingual product monographs so all new documents will be posted in both official languages. New procedures have been put in place so that the second language version is requested from the sponsor once the product monograph has been finalized during the submission review and authorized.
• For drugs that went on the market between January 2004 and January 2008, Health Canada is making every effort, through discussions with drug sponsors, to obtain as many French language versions as possible. Through these two actions, the database will have an increasing number of documents in both official languages.

E-Review

HPFB is migrating toward an electronic review environment that will support branch processes throughout the product life-cycle and across product lines. The e-Review initiative is intended to streamline the submission process, while increasing transparency, through implementation of an integrated and secure Information Management/Information Technology (IM/IT) architecture that facilitates the exchange of information and is aligned with international standards.

In 2007-08, key achievements under this initiative included:

• Implementation of a viewing tool (docuBridge) for the Electronic Common Technical Documents, eCTD) in the production environment and delivery of training to review staff.
• Development of guidance documents for the preparation and management of submissions in eCTD format.
• Establishment of business processes for the receipt, validation, processing and storage of eCTDs, supported by Standard Operating Procedures.
• Implementation of an electronic document management system for Drug Master Files.

Special Access Programme

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

Practitioners treating patients with serious or life-threatening conditions may request special access to a non-marketed drug or medical device in cases where conventional therapies have failed, are unavailable, or are unsuitable.

The SAP Comprehensive Review is multi-faceted involving several sub-projects, some of which have been completed. These include:

• A guidance document - developed to clarify the current scope and mandate of the SAP - posted in January 2008.
• An operational review was conducted to evaluate the functioning of the programme within its existing framework. A contracted report, delivered March 2008, evaluated current processes, resources, and technical support to the SAP. Work is on-going implementing recommendations. The core recommendation regarding database systems is work in progress.
• An ethics review was conducted to study the ethical context of the mandate and activities of the SAP. The goal of the project was to review the ethical dilemmas that are common to SAP requests and to develop an issues map and discussion paper that would identify important ethical themes and areas for future work. This review included the work of two external contractors with experience in public policy development and academic and applied ethics.
• A policy and regulatory review was initiated as an overarching examination of the SAP and our authority under the Food and Drugs Act and Regulations. This included an examination of the current special access Medical Devices Regulations, in order to determine if a change in policy direction was needed. Regulatory amendments, aside from Block Release, would follow from this work if needed. This review was designed to be highly consultative.
• External, "issue framing" consultations were held in the spring of 2007 to identify major issues associated with the SAP.
• An issue identification paper was posted to Health Canada's website in November 2007 for public comment in order to validate the issues identified within the current SAP frameworks.

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 2007-2008, 99.3 per cent of 2687 pharmaceutical Clinical Trial Applications and Amendments were reviewed within the 30 day default date, however for Clinical Trial Applications (CTAs) which have a 7-day service standard, this was met in only 76 per cent of cases.

Surveillance of the safety of Canadian participants in pharmaceutical clinical trials is ongoing. In fiscal year 2007-2008, we received and analysed 46,370 clinical trial adverse drug reaction (CT-ADR) reports which is a 34 per cent increase compared to fiscal year 2006-07. As well, of 86 safety signals identified, 12 received full assessment while 74 remain requiring further analysis. As a result of analysis of the CT-ADRs, clinical trial protocols and related documents were modified to better inform and to better ensure the safety of the participants in the trials.

In order to better support the life-cycle approach to regulating pharmaceuticals, the Clinical Trials Adverse Drug Reaction Division in the Office of Clinical Trials has completed a business transformation model to facilitate the implementation of the ArisG Canada Vigilance module for pre-market adverse drug reactions. It will support: 1) drug life-cycle management; 2) the analytical work and signal detection; 3) an efficient and accurate reporting of safety information. The implementation of such a system will enhance our ability to detect safety signals and monitor the safety of Canadian participants in clinical trials.

In 2005, Health Canada established an Investigational Testing Unit for the review of medical device investigational testing applications. The intent of which was to improve the department's ability to process increasingly complex technologies to be tested in clinical investigations, to ensure consistency and improved communication with internal and external stakeholders, and to improve monitoring and surveillance in this area.

Staffing of the unit is incomplete, and once acquired, the unit will be in a better position to address the increasing volumes and complexity of medical device Investigational Testing Applications (ITA), Revised Authorization requests (RA), and Adverse Event Incident Reports. The review workload in fiscal year 2007 for ITAs was 119 decisions on new applications, and for ITA-RAs, 173 decisions on modifications to applications, with authorization completed on time 70 per cent of the time. The decrease in performance from 2006 (92 per cent on time) is attributed to the utilization of resources from the review sections which were under pressure to also complete Class III and IV New and Amendment Applications, and to an increase in the number of combination product applications, which are reviewed jointly with Drugs.

Expedited Pandemic Influenza Drug Review (EPIDR)

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

In 2007-08, the AIDS and Viral Diseases Therapeutic area completed a draft Expedited Pandemic Influenza Drug Review (EPIDR) protocol. Further feedback on this initial iteration is being solicited, and a comprehensive external Issue Analysis Summary is being prepared to ensure that the proposed process will allow rapid and efficient review of flu drug submissions prior to and in the event of an influenza pandemic. Collaboration is also continuing with other areas of the Health Portfolio to ensure that the EPIDR protocol complements other ongoing regulatory initiatives aimed at facilitating expedited access to pandemic antiviral drugs and vaccines.

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 2007-2008 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.

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 2007-2008 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 2007-2008 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. Training sessions began in September 2007 with the majority (22) being completed. There were approximately 90 participants and the program was very well-received by TPD and BGTD.
• Office of Science provided numerous biostatistics courses via the Office of Continuing Education.

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 is 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 2007-2008 fiscal year towards Strategic Enabler: Relationship Management.

Bilateral Meeting Program

TPD hosted 20 regular bilateral meetings with 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.

In 2007-2008, a number of international arrangements were negotiated. A Memorandum of Understanding (MOU) regarding conformity of substances for pharmaceutical use was signed in March 2007 between HPFB and the European Directorate for the Quality of Medicines and Healthcare (EDQM). In addition, HPFB and the Therapeutic Goods Administration (TGA) of Australia signed an MOU regarding quality management system certification for medical devices. We also amended the scope of the existing MOU between HPFB and the United States Food and Drug Administration (FDA) to include the sharing and exchange of information about food and natural health products. As well, the directorate hosted various foreign delegations including Brazil's National Health Surveillance Agency (ANVISA).

In November 2007, TPD played a role in preparing the Director General for a broad range of meetings with Indian authorities from federal and state government and industry during a Drug Information Association (DIA) event in India.

In December 2007, HPFB signed a confidentiality arrangement through an exchange of letters with the European Commission (EC) and European Medicines Agency (EMEA). This arrangement allows for the sharing of information relating to therapeutic products (pharmaceuticals, radiopharmaceuticals, biologics and natural health products) for human and veterinary use.

In March 2008, HPFB and the State Food and Drug Administration (SFDA) of the People's Republic of China held their annual senior officials meeting in Ottawa. The purpose of the meeting was to report on progress made and discuss areas of common interest for collaboration under the Plan of Action. The Plan of Action is a cooperation mechanism that allows for the exchange of information relating to therapeutic products (pharmaceuticals, radiopharmaceuticals, devices, biologics and natural health products).

In 2007-2008, we continued to be involved in multilateral work within various fora:

• Various World Health Organization (WHO) initiatives, including participation in the Prequalification Programmes (PQP) and the Global Blood Regulators Network.
• North American Trilaterals;
• Heads of Agency Summits; and
• 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, including active participation in Pan American Network on Drug Regulatory Harmonization (PANDRH) initiatives.

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 regulatory practices and processes:

• International Conference on Harmonisation (ICH) activities, including participation on expert working groups involved in the development of international guidance, on the ICH Global Cooperation Group and newly created Regulators Forum, and as an observer to the ICH Steering Committee.
• Global Harmonization Task Force (GHTF) activities, including participation in the five study groups involved in the development of harmonized guidance documents and regulatory approaches for medical devices, and as current Chair of the GHTF Steering Committee.

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, HPFB This Week, kit folders, employee orientation guide, GRP Intranet, brochures and events such as all-staff meetings, Extended Management Retreats and Bilateral Meeting Program (BMP). 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 2007, fall 2007, winter 2007 and spring 2008) which were distributed in electronic format to all TPD staff and key external stakeholders.
• HPFB This Week: TPD regularly provides directorate news to the branch's weekly, electronic newsletter (20 submissions).
• News updates on GRP Intranet: The GRP Intranet is being updated every Friday with news that is relevant to the reviewer community and others who visit the GRP Intranet. An e-mail with a link to this news is sent out weekly to the review bureaus.

Communication Events:

• All Staff Meetings and Extended Management Retreats (EMRs): There were no directorate-wide all-staff meetings or EMRs due to financial constraints.

Future Plans for 2008-2009

1. Strategic Objective: Modern Legislative and Regulatory Framework

Product Lifecycle Approach

The PLA initiative has been transferred to the Policy, Planning and International Affairs Directorate and all reporting will come from branch reporting documents.

Schedule A

The department will revise the existing guidance document on Schedule A and Section 3 of the Food and Drugs Act to reflect the regulatory amendments that will come into force on June 1, 2008. In addition to describing the amendments, the guidance document will include a description of data requirements that will be required in support of preventative claims for the diseases and conditions listed in Schedule A. The department will also conduct, in 2008-2009, a consultation on this revised draft guidance.

Schedule F

Regulatory amendments to Schedule F are an ongoing activity. In 2008-2009, proposals to add approximately eight substances to Schedule F as well as the change in status from prescription to non-prescription for approximately three substances will be consulted on. It is expected that approximately nineteen substances will receive prescription status through publication in Canada Gazette, Part II.

Clinical Trial Registration and Disclosure

Policy discussions continue regarding the development of a regulatory requirement for this initiative through legislative modernization. Health Canada is also working on various options to create a Canadian portal to the existing clinical trial registries to make it easier for sponsors to register, and for Canadians to search for information in both official languages.

Notice of Compliance with Conditions (NOCc) Policy

TPD will advance the revision of the Notice of Compliance with Conditions (NOCc) policy to allow for generic drugs that reference a NOCc Canadian Reference Product. In addition, operational issues that impact the assessment of NOCc generics will be tracked and a working group will be established to provide input to policy development and ensure communication between affected TPD bureaus and other directorates.

Paperwork Burden Reduction Initiative

TPD will contribute to the department's reduction of requirements found in statutes, regulations, policies, forms and templates through various means.

2. Strategic Objective: Performance Sustainability

Review Performance

TPD's goal is to continue to achieve and sustain 90 per cent review on time during fiscal 2008-2009 for all new drug and generic drug submissions as well as class II, III and IV medical device applications.

Project/Workload Management

A new Submission Planning Project will begin to focus on new/ongoing Process Improvement Initiatives and Efficiencies. During Phase 1, a framework will be developed where activities and roles and responsibilities will be determined and SOPs will be drafted. Screening will take place in Phase 2. Phase 3 will comprise of two reviews where frameworks will be further developed and a pilot(s) will be conducted to verify changes. Submission Planning will be implemented across TPD in Phase 4 with an evaluation to follow.

Good Guidance Practices

Guidance documents in support of the Medical Devices Program will be prioritized and developed according to a list generated through TPD's work with Canada's Medical Device Technolog Companies (MEDEC). The Draft Guidance on Audit Reports and guidance on the "Quality Management Systems -Medical Devices- Control of Products and Services Obtained from Suppliers and Adult Hospital Beds: Patient Entrapment Hazards, Side Rail Latching Reliability, and Other Hazards" will be posted. The Guidance for the Interpretation of Significant Change V.3 (2003) will be updated, and new draft guidance documents "Medical Device Applications for Implantable Cardiac Leads" and the "Keyword Index to Assist Manufacturers in Verifying the Class of In Vitro Diagnostic Device" will be posted for consultation in fiscal year 2009-2010.

In fiscal year 2008-2009, the Bureau of Policy Science and International Programs (BPSIP) will continue to provide guidance development advice, consistent with GGP, on an ongoing basis to other areas of the program. A database will be designed to house a range of information regarding guidance documents currently under development. It is anticipated that the database will assist in tracking and reporting on TPD's guidance development activities. The ongoing integration of records management practices into guidance development will also continue.

The guidance needs assessment will be updated on a regular basis to reflect changing priorities, expectations and resourcing.

Administrative changes to ensure consistency between both French and English versions of the Priority Review for Drug Submissions Guidance Document will be completed after consultation with internal stakeholders and an analysis of the available points.

Good Review Practices

• Delivery of regulatory framework course pilot.
• Increased GRP communications via introduction of weekly mailings to review/RPM community.
• Increased GRP communications via introduction of monthly discussions with review/RPM community.
• Delivery of drug and device regulatory science values and ethics course pilot.
• Increased GRP communications via introduction of Web surveys for feedback on GRP products (e.g. SOPs and training courses).
• Finalize regulatory framework course and delivery to new TPD reviewers on a regular basis.
• Delivery of critical thinking and evaluations skills course pilot.
• Completion of Reviewer's SOP and Reviewer's Orientation binder content.

Enhanced Review Capacity

Scientific Advisory Bodies

Scientific Advisory Committees

• Two meetings are scheduled for November 5, 2008 for the Scientific Advisory Committee on Medical Devices used in Cardiovascular Systems (SAC-MDUCS).
• One meeting is proposed for spring 2008 for the Scientific Advisory Committee on Oncology Therapies (SAC-OT).
• One two-day meeting is tentatively scheduled for early December 2008 for the Scientific Advisory Committee on Respiratory and Allergy Therapies (SAC-RAT).
• One new committee is going to be developed called the Scientific Advisory Committee on Cardiovascular Therapies. The election call will delay us but we hope to be ready for the inaugural meeting in the late winter 2009.

Scientific Advisory Panels

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

Enhanced Contracting Capacity

• Enhancements/changes will be made to the existing database and a revised version will be deployed to users.
• The SED will be expanded to other directorates and documentation will be provided to users for feedback on changes/enhancements to current product. Input will be captured in a Master Copy and a new brochure. Work will begin on a new MOU and a new contracting process will be finalized for use with other directorates.
• Several associations will be contacted inviting their membership to apply. The Office of Science will do a mail out to current SAP/SAC members inviting them to register.
• Weekly status update meetings will be held to discuss pending contracts and other business issues.
• There will be an analysis of financial reports to ensure budgets on target and contracting dollars remain available as required.

Summary Basis of Decision

• SBDs will continue to be published for all authorized New Drug Submissions (NDS) for New Active Substances (NAS) and a subset of Class IV medical device applications. Revised SBD templates will be published for drugs and devices.
• SBD Evaluation will begin with an action plan approved by TPD and BGTD-MCs followed by data collection and analysis, and the preparation of an evaluation report. The report, including its recommendations, will be presented to TPD and BGTD-MCs.

Product Monograph

Product Monographs will continue to be posted.

E-Review

The final guidance for industry "Preparation of Drug Submissions in eCTD Format" will be published.

Sustain electronic submissions

• CTA / CTA-A - Publication of guidance for industry.
• Medical Devices - Develop plan and Business Requirements Document for implementation of electronic submission of medical device class IV applications.
• Provide external reviewers access to electronic submissions using docuBridge.
• Medical Devices - DocuBridge configuration for Medical Device applications.
• CTA / CTA-A - Implementation of electronic submissions of CTA / CTA-A applications in production environment.
• DIN - Implementation of docuBridge for DIN electronic submissions (including Disinfectants).
• DMF - Develop plan and Business Requirements Documents for electronic submission of Drug Master Files (DMF).
• Provide access to DocuBridge internally to the Office of Science and Records Management and externally to the Inspectorate.

Secure Electronic 2-way Communication

• Develop a Vision and Scope document for Clarification On-Line.
• Convert DSTS Industry Access (DSTS-IA) to bilingual compliancy, common look and feel (CLF) and current IT standards.
• Secure Channel integration estimate for the DSTS-IA. Target DSTS-IA to go live on Secure Channel Network.

CT-ADR (Canada Vigilance System Implementation)

• Develop a Scope and Vision document
• Develop a Project Charter
• Receive a Business Transformation Report
• Develop a Statement of Work for Project
• Hire a Project Manager.

New Special Access Program (SAP) Database

• Develop a Contrast Report detailing business requirement/ environmental scan.
• Develop a Statement of Work (SOW) / Request for Proposal (RFP) for Project Manager (Fall 2008).
• RFI software product.
• Establish a sole source contract for program development replacement oracle database to replace the DOS database as risk mitigated strategy.

Special Access Programme

The SAP Comprehensive Review will modernize the regulatory framework and further define the Programme's mandate and authorities while establishing an ethical framework for permitting compassionate access to new therapies outside clinical research. Overall completion is targeted for 2009.

SAP Operational Review

Recommendations of the review will continue to be implemented and the staffing of a pharmacist or physician for monitoring drugs accessed through SAP will be be pursued.

SAP Block Release Regulatory Amendment

Progress will be made on the resubmission of the RIAS and Performance Measurement Evaluation Plan according to the new requirements implemented by TBS. As well, a cost-benefit analysis will be developed. Submission for pre-publication in Canada Gazette I and final publication in Canada Gazette II will follow.

SAP Ethics Review

Ethics Review Report will be delivered and its contents will be incorporated into the Options Discussion paper for Broad Policy Review.

SAP Guidance Document

Complete Guidance Document on current framework.

SAP Broad Policy/ Regulatory Review

An Expert Advisory Panel will be convened to study the policy options discussion paper.

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 continue towards implementation of the Canada Vigilance System in the ADR division to improve TPD's capacities to carry out pre-market safety surveillance. Revise Project Charter and obtain signatures. Plan implementation of pre-market Canada Vigilance Plan (CVP).
• Scientific advice and interpretation on drug issues related to clinical trials will continue to be provided.
• We will continue to respond to enquiries 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 guidance.
• Align scientific expertise of staff to mirror increase CTA workload in specific clinical areas (e.g., 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.
• Working group to be established in fiscal year 2008-2009 to deal with issues related to conformity with Good Clinical Practices in foreign conducted clinical trials.

Investigational Testing:

• Ongoing 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.
• Bureau presentations are to be delivered at industry and professional meetings and workshops.

Expedited Pandemic Influenza Drug Review (EPIDR)

• Completion of EPIDR-Issue Analysis Summary and EPIDR plan draft.
• Directorate Management Committee approval of the IAS and plan.

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.

4. Strategic Enabler: People

Training

• The Competency-based Management Training Program (CBMTP) will be completed.
• TPD will continue to deliver a biostatistics course via the Office of Continuing Education.

5. Strategic Enabler: Relationship Management

Bilateral Meeting Program

• The Bilateral Meeting Program will continue to host regular bi-lateral meetings with 13 national stakeholder organizations.

International Regulatory Cooperation

Cooperation with the United States FDA

To determine effectiveness of using multi-purpose audits conducted by third party auditing organizations of medical device manufacturer's quality systems to fulfill both United States and Canadian regulatory requirements we will:

• Complete multipurpose audits under the pilot to date; target of 10 by end of Q4/beginning of Q1 (2009).
• Engage the FDA's Office of Pharmaceutical Sciences in conducting a parallel assessment of applications that describe Quality by Design approaches to the control and manufacture of pharmaceuticals, thereby enhancing our experience with the implementation of the science and risk based concepts embodied in the more recent ICH Quality guidance.

Cooperation with EDQM

• Pilot the use of Certificates of Suitability (CEPs) in the review of drug submissions by TPD for active pharmaceutical ingredients (APIs) only;
• Conduct an assessment to determine the use of CEPs in achieving greater review efficiencies.
• Review TPD's use of EDQM certificates of suitability for drug substances with a view to moving into the third phase of a project that would in the end allow for the filling of certificates in lieu of Drug Master Files.

Cooperation with TGA

• Reciprocal recognition of Quality Management System Certificates for medical device manufacturers selling, or wishing to sell medical devices in each other's jurisdiction.
• Completion of observed audits: (1) HPFB to observe audit of Australian manufacturer by the TGA (Office of Manufacturing Quality) to Canadian requirements.
• TGA to observe audit of Canadian manufacturer by a Health Canada recognized Registrar to Australian requirements.

TPD will contribute to the agenda and organization of Health Canada's components of the International Conference of Drug Regulatory Authorities (ICDRA) symposium in Switzerland in the fall.

TPD will advance a proposal for an International Training Forum aimed at converting the various ad hoc visits by international delegations into scheduled sessions available to all interested countries.

International Harmonization

International Pharmacopoeias and 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 guidance, as observer to the ICH Steering Committee, and as regulatory co-chair of the Global Cooperation Group (GCG).

Draft Guidelines to be Released for Comment

• Release of Draft (Step 2) "International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Annex 6 to ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Uniformity of Dosage Units General Chapter."
• Release of Draft (Step 2) "International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Annex 7 to ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter."
• Release of Draft (Step 2) "International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: Annex 8 to ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test General Chapter."
• Release of Draft (Step 2) "International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: ICH S9 - Nonclinical Evaluation for Anticancer Pharmaceuticals."
• Draft Step 2 "ICH Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use."

Efficacy

• Post guidance document: "Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories, ICH Topic E15."

Communications

Communications Products

• TPD News will continue to be produced quarterly.
• Regular updates will be provided for the HPFB This Week.
• Surveys will continue to be used to evaluate programs and initiative.
• News updates to GRP Intranet will continue.