Business Transformation Annual Report 2005-2006

Date: 2007-04-11

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Table of Contents

Message from the Director General

Who We Are

TPD Vision
TPD Mission

Health Canada's Therapeutics Access Strategy

Business Transformation Strategy

Our Results

Project/Workload Management
Good Guidance Practices
Good Review Practices
Transparency
E-Review
Enhanced Review Capacity
International Regulatory Cooperation
International Harmonization
Change Management

Future plans 2006-2007

Project/Workload Management
Good Guidance Practices
Good Review Practices
Transparency
E-Review
Enhanced Review Capacity
International Regulatory Cooperation
International Harmonization
Change Management

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Message From The Director General

I am pleased to present the Therapeutic Product Directorates' third Annual Business Transformation Progress Report which outlines our accomplishments to improve the timeliness of the regulatory process for pharmaceutical submissions and medical device applications. 

Through the dedication and hard work of TPD staff, we have succeeded in our commitment to Canadians to improve accessibility to pharmaceuticals and medical devices. In September 2005, the target of reviewing 90 per cent of new pharmaceutical drug submissions in time was achieved. The number of pharmaceutical submissions in queue, and their duration in queue, was reduced. Progress on the medical device side was also impressive. The backlog for Class III and IV device submissions was reduced from 25 per cent in January 2005 to 1.1 per cent by March 31st 2006.

Our commitment has been achieved through the substantial investments we have made in the areas of project management, enhancing review capacity, as well as the development of good guidance practices and good review practices.  

We are also committed to providing Canadians with information via the Summary Basis of Decision and Product Monographs to support informed treatment choices.

As we move forward, the importance of working with our international colleagues through the International Regulatory Cooperation and International Harmonization projects will increase as we learn from one another and investigate sharing responsibilities and streamlining processes. 

Together these initiatives will lay a strong foundation for a better regulatory system as well as improving the quality of life for Canadians, and building a better future for health care in Canada.

I trust that you will find this annual report useful and informative as it reinforces our commitment to ensure that our regulatory system is improved and Canadians have better access to the pharmaceuticals and medical devices they need.

Omer Boudreau
Director General
Therapeutic Products Directorate

Who We Are

The Therapeutic Products Directorate (TPD) is the Canadian federal authority that regulates pharmaceutical drugs 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, as required by the Food and Drugs Act and Regulations. The numerous activities of TPD that contribute to the regulatory review process are accomplished through the dedicated work of more than 500 employees.

The following bureaus comprise TPD:

• Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)
• Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD)
• Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)
• Bureau of Pharmaceutical Sciences (BPS)
• Office of Risk Management (ORM)
• Office of Clinical Trials (OCT)
• Medical Devices Bureau (MDB)
• Office of Patented Medicines and Liaison (OPML)
• Bureau of Policy, Science and International Programs (BPSIP)
• Submission and Information Policy Division (SIPD)
• Office of Business Transformation (OBT)

TPD 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.

TPD Mission

We contribute 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.

Health Canada's Therapeutics Access Strategy

Health Canada established the Therapeutics Access Strategy (TAS) to effect regulatory performance improvements and meet federal government commitments in a comprehensive manner.

These commitments are outlined as follows:

• The 2002 Speech from the Throne included a commitment to renew federal health legislation, a commitment to smart regulations, and a commitment to improve the timeliness of the regulatory process for therapeutic products to ensure that Canadians have faster access to the safe drugs they need;
  
  
• In the 2000 and 2003 First Ministers' Health Accords, first ministers agreed to work together on approaches to ensure that Canadians continue to have access to new, appropriate and cost-effective drugs.
  
  
• Budget 2003provided $190 million over five years to improve the timeliness of Health Canada's regulatory processes with respect to human drugs, while preserving the principle that safety is of paramount concern.

TAS builds on and supports many of the activities already under way to strengthen Canada's regulatory system for therapeutic products.

The strategy has three interrelated objectives:

1. Transforming the regulatory performance by improving the timeliness and transparency of the review process for therapeutic products, while maintaining Health Canada's high standards for safety;
   
   
2. Enhancing post-market surveillance by exercising greater vigilance around safety and therapeutic effectiveness issues once products reach the market; and
   
   
3. Improving access to appropriate and cost-effective drug therapies for Canadians, which contributes to the sustainability of the health care system.

Business Transformation Strategy

The Business Transformation Strategy defines how TPD will meet the Government of Canada's commitment to effect performance improvements. The strategy consists of a number of mutually supportive initiatives to achieve a drug review process that is timely, consistent, transparent, predictable and sustainable.

The purpose of the Business Transformation Strategy, which predates the Therapeutic Access Strategy, is to deliver on the government's commitment and to position TPD as a contemporary regulator.

TPD is committed to delivering on eight identified initiatives to move TAS forward and meet established goals with the dedicated funds provided to this end. The following are the eight initiatives:

• Project Management
• Good Guidance Practices
• Good Review Practices
• Enhanced Review Capacity
• International Regulatory Cooperation
• E-Review
• Transparency
• Change Management

Our Results

Project/Workload Management:

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 will be managed as projects with the necessary planning, coordination and management of activities, to oversee completion of reviews within performance targets.  The approach will also ensure that appropriate review targets are set and monitored for each submission/application, issues are identified early, actively dealt with and resolved, and that the submission/application is not delayed. Also, one person (the Regulatory Project Manager) will always know the status of the submission/application and will be 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 workload related to the review process.  It provides a snapshot via the Drug Submission Tracking System (DSTS) of how many drugs are being reviewed and the workload status. This initiative provides an ongoing assessment of the progress of review on each submission and an insight on workflow trends in order to take proactive measures. The current focus is on new drugs, excluding notifiable changes.

The following are some of the specific achievements of the Project/Workload Management Initiative:

• During fiscal year 2005-2006, regular bi-monthly reports were issued to the Senior Regulatory Project Managers (SRPMs), providing information on: age stratification of the current workload; the number of new drug submissions (NDS) in workload; screening deficiency notices; NODs and NONs issued relative to total; the number of NDS meeting performance targets relative to total (90 per cent); number of NDS in backlog relative to the baseline date of March 31, 2003; and backlog stratification by age.
  
  
• Additional bi-monthly reports were developed throughout the year to expand reporting to screening performance for NDS, and screening and review performance for Notifiable Changes and DIN submissions.
  
  
• A workload management forum has been introduced. This monthly meeting gathers the Director General, Review Bureau Directors, Review Division Managers and Senior Regulatory Project Managers in a full discussion of the NDS, NC and DIN workload. This periodic meeting permits accounting of full workload, and sharing of best practices and challenges in a collaborative and collegial environment. A similar higher level presentation is made monthly to the Directorate Management Committee (DMC).
  
  
• Positive feedback continues to be regularly received. The progress of the initiative has prompted increased dialogue on proposed submission filings, progress of submissions and internal processes with the aim to enhance workload management planning and process efficiencies.  External clients continue to observe the link between the introduction of Regulatory Project Managers 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.
  
  
• Two vacant positions and a new position were all staffed from the Senior Regulatory Project Manager competition that was completed in January 2006. The addition of the new position has brought an improved focus to the creation and structure of Regulatory Project Management Division (RPMD) Standard Operating Procedures (SOPs). As a result, separate brainstorming sessions for both the RPMs and the Submission Coordinators have occurred to determine SOP needs and prioritization for the two sections of the Division.  A development plan for the RPM SOPs has been created and similarly, this will be done for the Submission Coordinator SOPs. One additional SOP was finalized over the last fiscal year and approximately 15 master SOPs are either in development or will be initiated during the upcoming year.  Each SOP category will result in the creation of further sub-SOPs.
  
  
• Additional RPMs were hired to service divisions that were understaffed (the Metabolic and Musculoskeletal Drugs Division and the Oncology Division).  Further expansion of RPM service included hiring an RPM to service the Disinfectant Unit, which reviews lower risk products that were not actively project managed and to more actively project manager other complex DIN submissions by an existing RPM.  Two and four Regulatory Assistants (students) were hired in order to help ease the RPM workload as well as to create future opportunities for student bridging to fill future RPM vacancies. The remaining vacant Regulatory Project Manager positions were filled throughout 2005-2006 to replace RPMs who have deployed out of the program. There are currently 21 Regulatory Project Managers (one of whom is acting as an SRPM).
  
  
• An RPM training program is being developed that will 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.  The SRPM recently hired to focus on training and SOPs will provide more structure to this program.
  
  
• On-the-job training is being provided to the RPMs.  This is being done both via one-on-one training by the SRPMs, as well as job-related training sessions for the RPMs as a group that relate to various policies, procedures, and regulatory initiatives. General training has been provided to existing RPMs; however training is continual for new and existing staff.
  
  
• Every RPM employee has attended the Project Management Training Program intended for all TPD employees. New RPMs will also attend the training regime.
  
  
• Further to the preliminary MS Project training conducted in the summer of 2004, every RPM employee has received a more extensive customized MS Project training in February 2006. They all have MS Project on their desktops and are using it to create review plans.
  
  
• A submission review Work Breakdown Structure (WBS) was developed and finalized in January 2003. Revisions to the WBS will be made on an ongoing basis as process improvements take place. An internal working group has recently been established to create a standard abridged version of the Submission Review WBS as well as to ensure the consistency of review plans based on this WBS. As part of the review plan, defined milestones and a scientific review team are established at the outset of the review of each submission, which is an ongoing activity. These milestones will be based on the needs of the submission, review resources available, and scientific complexity.

Good Guidance Practices:

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

The following are some of the specific achievements of the GGP initiative:

• The GGP working group drafted a GGP manual that is intended to be an electronic resource for issue analysis and guidance development in TPD and Biologics and Genetic Therapies Directorate (BGTD). Its chapters include: guiding principles, definitions, roles and responsibilities, procedures, templates, style guide and a lexicon. Internal consultations with TPD and BGTD were held during the third quarter and as a result, revisions have been made.
  
  
• Formal training will be conducted as part of the implementation of the GGP Manual. Internally, informal communication has been conducted as part of the consultation process. Externally, updates on the project have been given at TPD-industry association bilateral meetings.
  
  
• The needs assessment exercise with both internal and external input was initiated in 2004 and continued throughout 2005-2006. The working group prioritized a list of guidance needed, guidance to be revisited and guidance from other jurisdictions to be considered for adoption. Ideas that are further provided for guidance development will continue be added to the list.

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.

The following are some of the specific achievements of the GRP initiative.

• A finalized template for the safety and efficacy review of pharmaceutical submissions was completed during the fourth quarter of 2005-2006. Once implemented, this will ensure that reviewers are provided with a standard format for the development of review reports.
  
  
• In collaboration with the Office of Information Management and Technology, a GRP Intranet was piloted during 2005-2006. Once finalized, it will provide reviewers with a comprehensive resource tool that can be accessed from multiple locations.

Transparency:

The Transparency Initiative aims to strengthen Health Canada's position as a transparent regulatory authority and to provide information to Canadians about the benefits and risks of therapeutic products. As a result of transparency efforts, Canadian healthcare professionals and patients will have more information at their disposal to support informed treatment choices.

Summary Basis of Decision:

The goal of the Summary Basis of Decision (SBD) initiative is to develop and implement a process to publish documents for public consumption that summarize and explain product-specific regulatory decisions.  The documents will include regulatory, safety, efficacy, and quality considerations.

The following are some of the specific achievements of the SBD initiative:

• In 2005-2006 the technical writer infrastructure was stabilized for TPD/BGTD. The technical writers are responsible for drafting SBDs for drugs, medical devices and biologics.
  
  
• Drugs, medical devices and biologics all currently have standard operating procedures in place, which are revised, based on experience with the documents.
  
  
• Background materials, such as a Fact Sheet, Frequently Asked Question document and Readers Guides were completed and published in the summer of 2005. This background information is in direct response to messages gleaned from participants at external consultation venues.
  
  
• Phase one implementation was initiated in January of 2005 with the preparation and publication (to TPD/BGTD Web sites) of SBDs for approved submissions for New Active Substances (New Drug Submissions) and a subset of Class IV medical device applications. These subsets of submissions and applications were chosen for their linkages to HPFB priorities of providing timely access to new and novel therapies.

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.  The Product Monograph Project is developing a plan to make product monographs publicly accessible.

• A review of implementation challenges regarding the submission of Product Monographs is currently underway and a revised implementation plan will likely result in order to address sponsor and reviewer concerns.
  
  
• The Product Monograph working group has been developing an Issue Analysis Summary (IAS) to advise internal and external stakeholders on some of the issues involved in making the product monograph publicly accessible, and to solicit feedback on proposed options. Once completed, the IAS will conduct internal and external consultations (with affected stakeholders), by such means as mailouts, Web postings, and/or focus groups during the second quarter of 2006-2007.

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 and 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 and the Health Product and Food Branch's key strategy to improve transparency, openness and accountability.

Following the 2004 evaluation of TPD's BMP, an action plan was implemented to address recommendations identified by the evaluation, thereby improving the BMP and maintaining its utility.

• TPD and HPFB BMP Networks were established to improve communication and coordination of meetings.
  
  
• New Agenda and Agenda Item Summary templates were adopted to provide more process structure and improve overall meeting management.
  
  
• TPD assumed the responsibility of preparing meeting notes and actions are being more proactively tracked and reported on throughout the process for purposes of accountability and update.
  
  
• A BMP document was created to provide the purpose, structure and process with clearly outlined roles and responsibilities.

E- Review:

The E-Review Initiative makes contributions towards Health Canada's Therapeutic Access Strategy, by establishing an electronic review environment that will offer Information Management and Information Technology (IM/IT) tools and provide support to the electronic submission and review of health products that Health Canada has regulatory authority over, as outlined in the Canadian Food ad Drugs Act.

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

• Handling electronic Common Technical Document (eCTD) based submissions for therapeutic products
• Special Access Program
• Clinical Trial Adverse Drug Reaction

The following are some of the specific achievements of the E-Review Initiative.

• The electronic document management component of the GoC Records and Document Information Management System (RDIMS) was implemented in TPD for a specific review process. RDIMS is a suite of software applications designed to provide federal government departments and agencies with a standard software solution for records and document management.
  
  
• The Special Access Program pilot was developed for TPD (targeted for production release in 06-07).
  
  
• The Clinical Trials Adverse Drug Reaction pilot was developed for TPD and BGTD (targeted for production release in 06-07).
  
  
• Continued the essential work to establish the legal/privacy framework, build the Information Technology security infrastructure, and formulate project management best practices.
  
  
• Provided technical support to E-Review business partners in keeping pace with the international standards for electronic submissions in eCTD format.
  
  
• Developed and piloted an interim viewing tool software solution for eCTD format. This allows TPD and BGTD to review eCTD format submissions electronically in both paper co-submission and hybrid filing formats.
  
  
• Launched, evaluated and selected a long-term viewing tool through a procurement process led by PWGSC. The long-term viewing tool is one of the main components of the E-Review suite of solutions and is planned to be implemented and deployed in 06-07.
  
  
• OIMT Infrastructure Lab which was built to support the technical design, testing and Proof of Concept (PoC) functions of different E-Review solutions.
  
  
• E-Review supported its Business Partners' release of the Guidance for Industry: Preparation of Drug Submissions in the eCTD Format. This guidance document will assist sponsors in the preparation of drug submissions in the electronic Common Technical Document (eCTD) format.

Enhanced Review Capacity:

The Enhanced Review Capacity Initiative is one of TPD's Business Transformation Initiatives created in response to Health Canada's Therapeutic Access Strategy.

This 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 - One deals with the creation and maintenance of scientific advisory bodies such as Scientific Advisory Panels (SAP) and Scientific Advisory Committees (SAC). The other relating to the Enhanced Review Capacity is outlined below.

The Enhanced Review Capacity Unit was created in 2004 to provide centralized contractual services. TPD's goal is to increase the use of scientific contracts and subsequently 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:

• Therapeutic Class Specific Standing Committees:
  • An expert advisory panel was established for both COX-2's and Breast Implants.
  • Two scientific advisory committee meetings were held. These included an oncology and MDUCS meeting.
  • Six scientific advisory panel meetings were held. These included three meetings on reprocessing of medical devices, a meeting on nitric oxide, a meeting on isotretinoin and a meeting on schedule A.
  • Membership nominations were received for the scientific advisory committees of Respiratory and Allergy Therapies, Muculo-skeletal therapies and Endocrine and Metabolism Therapies and Metabolism Therapies and Neurological Therapies.
  • Scientific advisory panel bioequivalence requirements are currently being formed for fentanyl patches.
  • Scientific advisory committee paediatric therapies are currently being formed

In relation to Enhanced Contracting Capacity:

• A draft Letter of Invitation (LOI) for scientific expert contracting was developed and circulated for comments and approval. This document has been revised to meet Web requirements and will form part of our Web site where individuals will be invited online to apply to be part of our inventory.
  
  
• The Enhanced Review Capacity Team is currently in the process of finalizing the process maps for the contracting process and transferring them into Visio along with a text version of the required steps using the standard guidance template developed by GGP.  These will be provided to the Review Bureaux Directors as an information piece and will be further elaborated upon in the individual meetings with each Review Bureau and used in the process map training which will also be provided at a later date.
  
  
• An external consultant was hired to develop the new Web based database that will house pre-qualified potential candidates for contracts and Scientific Advisory Panels and Committees. The external portion of the database is almost complete as the User Acceptance Testing phase is nearing end. The internal application which is housed on a HC server is now in the process of being finalized.  Further testing will be required prior to going live with the final database and Web site. All other internet requirements such as a Preliminary Privacy Impact Assessment (PPIA) and a Threat Risk Assessment have been completed and a  Personal Information Bank number has been requested. User training and a user guide will also be provided to those TPD staff accessing the database.
  
  
• Several Review Bureaux 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.  We continue to canvass our internal staff for potential additions to the inventory.
  
  
• In order to increase the inventory, contact was made with specific medical associations, research and medical institutions, universities and other organizations where potential contractors could be found. As well, attendance and distribution of fact sheets at conferences, workshops, seminars, etc, has helped to spread the word and has attracted the interest from many scientific experts willing to work with us. Attendance at the University of Toronto job fair for Pharmacology students was also helpful in gathering CVs for an upcoming contractual requirement. Future plans may include being present at other similar events.
  
  
• A marketing brochure was created which provides information on potential work with Health Canada as well as the URL for online registration.  This will be mailed out to potential scientific advisors inviting them to become part of our database inventory.  The first mail out is scheduled for summer 2006.

International Regulatory Cooperation:

The International Regulatory Cooperation (IRC) Initiative involves using TAS targeted funding to further develop and strengthen relations with other regulatory authorities and with international health organizations in order to provide for 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 exchange, training, participation on external and internal scientific committees and joint projects. The recent negotiation of a memorandum 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, outcome-based approach being taken with regards to IRC in TPD.

The following are some of the specific achievements of the IRC initiative.

• Following the completion of the HPFB IRC Strategy in February of 2006, a first draft of the TPD IRC Strategic Framework was developed. The final version is expected to be completed in September 2006.
  
  
• Ongoing training continues to be delivered within TPD on good inter-agency practices regarding communication and confidentiality issues stemming from the signing of MOUs with other regulators and organizations.
  
  
• TPD continues to contribute to the development of a Branch SOP on the sharing of non-public information with other regulators. A draft HPFB SOP is expected in June 2006.

 Center for Drug Evaluation and Research (CDER)- Pharmaceuticals

• Ongoing discussions between TPD Review Bureaux and CDER Review Divisions continued throughout 2005-2006. TPD maintains an inventory of all information exchanges and communications. In the 2005 calendar year, there were over 30 interactions mostly to discuss review issues and post-market safety issues.
  
  
• The CMC Reviewers Discussion Forum (an initiative under the Framework for Cooperation on Product Quality) was postponed from May 2005 until May 2006.

Center for Devices and Radiological Health (CDRH) - Medical Devices

• In November 2005, officials from the U.S. Food and Drug Administration (FDA) and CDRH visited Health Canada's Ottawa offices for a two-day meeting.  The discussions that took place were a direct follow-up to an August videoconference and March senior officials meeting in Washington, which resulted in agreement between the two organizations to proceed with the development of a Pilot Multipurpose Audit Program (PMAP). The PMAP is a learning opportunity and allows both sides to exchange and use regulatory information as well as to take steps to address the key deliverable identified under the Security and Prosperity Plan (SPP):  the reduction of Quality System audits by third parties.
  
  
• A joint project plan is currently under development as well as a PMAP Audit Process and Audit Plan.  Both organizations will be issuing notices to industry and manufacturers and Registrars/Auditing Organizations will be identified to participate in this project.

Cooperation with Europe

• In March 2006, the European Medicines Evaluation Agency (EMEA) and TPD posted the first ever joint guidance document developed by the two organizations. The guideline on the "Pharmaceutical Quality of Inhalation and Nasal Products" was posted to the Health Canada Web site on April 13, 2006. Discussions will be held on more formalized cooperation with EMEA at the ICH meetings in Yokohama, Japan, in June 2006.
  
  
• TPD reviewers participated in an EDQM review session in November 2005, complimenting the confidence building activities being undertaken regarding the EDQM Certification Program.  It is expected that TPD will participate in three more sessions in 2006-2007. Work on the comparative assessment of TPD and EDQM reviews is ongoing and a final report is expected in August of 2006. Completion of the TPD-EDQM MOU is also expected in the fall of 2006.

Cooperation with the State Food and Drug Administration of China ( SFDA)

• Cooperation with the SFDA is seen as a strategic investment, as the agency continues to strengthen and modernize its regulatory regime and thereby exercise more effective control over domestic and exported products, including active pharmaceutical ingredients and Traditional Chinese Medicines destined for Canada.  These trends are expected to increase dramatically.
  
  
• Senior HPFB officials concluded a productive meeting in Ottawa in April 2005.  Officials agreed to hold the next meeting in Beijing in the spring of 2006.
  
  
• Prioritization of proposed work plans activities is underway with regards to pharmaceutical quality, clinical trials and medical devices.  Agreed upon priorities and work plans will be confirmed at the next Senior Officials Meeting (SOM) as well as a signing of extension for the HPFB-SFDA Plan of Action.

Cooperation with the Therapeutic Goods Administration of Australia (TGA)

• Negotiations are underway between TPD and the Australian Therapeutic Goods Administration for the purpose of developing an MOU regarding the reciprocal recognition of quality system certificates issued for manufacturers of medical devices. The aim of this collaborative undertaking is to facilitate access to medical devices in each others markets while maintaining high regulatory standards for these devices.
  
  
• Negotiations are now entering the confidence building phase. A rigorous confidence building framework has been developed that includes, but is not limited to a review of documentation and audits of each others processes, procedures and systems for conducting audits of manufacturers quality management systems. The confidence building exercise will also include observed on-site audits of medical device manufacturers.

International Harmonization:

Harmonization and IRC activities are related initiatives under the Therapeutics Access Strategy but are reported separately. The International Harmonization Initiative under TAS 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. 

The following are some of the specific achievements of the International Harmonization initiative:

International Conference on Harmonization

• Over the last fiscal year, TPD continued to actively participate in all ICH-related activities, most notably participation in expert working groups that are involved in the development of international guidances.  The most recent Steering Committee and working group meetings were held in Chicago in November 2005.
  
  
• In the capacity of co-Chair of the Global Cooperation Group (GCG), the Canadian observer (represented by TPD) and European industry co-chairs conducted a successful meeting of the GCG at the Chicago meeting in November 2005. Canada presented on preliminary results of a survey conducted among the Regional Harmonization Initiatives (RHIs) represented on the GCG.  Health Canada and the FDA also presented a draft strategy on training and capacity building for discussion.
  
  
• Steering Committee discussions around the future of ICH continued.  A new topic, "Quality Systems" (Q10) was approved by the Steering Committee. This proposed guideline will augment existing Good Manufacturing Practices with modern quality systems elements.  Several meetings were held to discuss potential future ICH topics in the areas of Biotechnology, Pharmacogenomics, and Pharmacovigilance.
  
  
• Guidances reaching Step 4 (final) in November 2005 included Pharmaceutical Development (Q8), which describes what should be submitted to a regulatory authority in the relevant section of the Common Technical Document (ICH topic M4); and Quality Risk Management (Q9), which provides principles and examples of quality risk management that can be applied to all aspects of developing a medicinal product, submitting to a regulatory authority, and for manufacturing sites inspections.

Pan-American Network of Drug Regulatory Harmonization (PANDRH)

• 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. Coordinated activities for drugs (including medicinal plants) are coordinated through the Pan-American Network on Drug Regulatory Harmonization (PANDRH). Following a successful 4th Pan-American Conference on Drug Regulation in March 2005 and associated Steering Committee meetings for PANDRH, the next scheduled Steering Committee meeting will be held in June 2006 in Washington.
  
  
• TPD continues to participate in three expert committees involved in standards setting and drug information.

Pharmacopoeias

• Two HPFB observers, one from BGTD (lead on biologics) and one from TPD (pharmaceuticals), continue to attend the meetings of European Pharmacopoeia Commission. The Commission met in June, November and February and proposals are to be developed for TPD participation in selected European Pharmacopoeia expert groups.
  
  
• TPD continues to participate in expert committees of the United States Pharmacopoeia (USP).

Change Management

Change Management refers to how an organization prepares, monitors, and evaluates the impact of change on its people and its process.  In support of the various changes that TPD's Business Transformation Strategy will bring, the Change Management Initiative will focus on four interrelated activities:  internal communications, learning opportunities, engagement events and community of practice opportunities to help staff understand and prepare for the organizational changes.

The following are some of the achievements of the change management initiative:

Communication Products:

• The Business Transformation Division continues to produce a quarterly newsletter entitled TPD News to communicate items of interest to TPD staff. Over the course of the last fiscal year, four issues were produced, which were distributed in hard and electronic format to all TPD staff as well as other key internal and external stakeholders.
  
  
• During the course of the year, three separate communiqués were released in electronic format to TPD staff in order to communicate the results of various meetings. These included the Managers Forum communiqué in June 2005, the TPD re-organization communiqué in December 2005 and the All Staff communiqué in March 2006.
  
  
• To communicate the directorate's success in eliminating the backlog, a news special was released in electronic format to all TPD staff in May, 2005.
  
  
• In support of its continuous improvement efforts, TPD conducted its third annual change management survey in October 2005. The survey builds on the August 2003 and November 2004 surveys.  The 2005 survey maintained some of the baseline questions on project management and communications found in the previous surveys and introduced new questions in the areas of planning and leadership.  The results of the survey were communicated to staff via e-mail.
  
  
• An HPFB Peer Survey was conducted in support of environmental scanning preceding the strategic planning process. The purpose of the survey was to obtain feedback from HPFB senior and middle managers (excluding those in TPD) on TPD's performance based on their experience and/or observation of TPD.  These results give a sense of where TPD stands in their working relationships with their Branch peers and help to identify gaps where improvements could be made.

Communication Events:

• Two All-Staff meetings were held over the course of the fiscal year. The first was held in June 2005. It was a short meeting, which outlined TPD's corporate priorities. The second was held in February 2006. It introduced the directorate's new strategic plan. The meeting provided staff with the opportunity to review the plan, develop a common understanding of its objectives and share their experiences and ideas on moving forward.
  
  
• A Senior Management Retreat was held in October 2005 to set the direction for the next three to five years, identify transformative initiatives to support our future direction and to assess and strengthen our management team, workforce and workplace. The two key strategic objectives identified were modernization of the regulatory framework and sustainable regulatory performance.
  
  
• An Extended Management Retreat was held in December 2005. The objectives of the retreat were the same as the Senior Management Retreat, with extended management building on the ideas and decisions that were developed at the Senior Management Retreat.
  
  
• Two Advisory Committee Management Meetings were held over the course of the fiscal year. The first was held in May and covered such topics as, safety agenda, pre-market initiatives and performance, improving access to safe and effective therapies and planning for the medium and longer term. The second was held in November and covered the HPFB strategic agenda, health product safety boards, policy on public involvement in the regulatory process, product classification, reporting on regulatory review performance, backlog reduction strategy, update on preparations for pandemic influenza, clinical trials, renewal of medical devices program, product licensing framework and national pharmaceuticals strategy progress report.

Training:

The TPD-specific training programs are focused on providing TPD staff and management with the skills and training required to be prepared for the upcoming cultural and organizational changes. These training initiatives support the achievements of TPD's strategic and ongoing objectives. These training needs are identified by management as part of the change management initiative.

All TPD-specific 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 2005-2006 were:

• Competency-Based Project Management Training Program: The majority of this training program was delivered in 2004-2005. The training has been extremely well received and is seen as essential for TPD staff. Managers have requested training for all new staff. Two training sessions were scheduled for new TPD staff on an as-required basis. The Project Management training received by TPD has provided a solid basis for knowledge of the best practices for project planning and the recognition of the benefits of project management.
  
  
• Competency-Based Management Development Training Program: A customized Management Development Program for the TPD management team was proposed and approved at DMC. This program will provide TPD Managers with a tailoredManagement Development Program to give them the required skills to enhance their success as a manager and move the organization forward. An extensive RFP process was run to select the vendor for TPD's Management Development Training Program. The project has been constructed on a phased approach to ensure that TPD's needs are being met at each stage and that TPD receives a high quality product. The vendor has been selected and work has commenced on the "Needs Assessment Phase".
  
  
• Customized PDP Training Program for managers and other staff: Based on specific TPD needs, a vendor was selected to customize, design and deliver PDP training to all TPD managers. Based on the focus group results from the needs assessment phase the requirement for a customized PDP session for all TPD staff was identified. The two programs (one for managers and supervisors and the other for non-managerial staff was designed, developed and piloted).
  
  
• Customized Workload Management Training for Bureau of Pharmaceutical Sciences: The BPS management team identified the need for an organizational skills, time management and workload prioritization training for their staff. The need was identified as a result of feedback from PDP discussions. A vendor was selected to further assess the requirements of individuals and the bureau. A customized workload management training program was designed, developed and delivered to all BPS staff.
  
  
• E-Learning Training Program for the Enhanced Review Capacity Initiative: The ERCU identified a requirement for an e-learning program for the external scientific expert consultants to help them provide a higher quality product.  A consultant was engaged to develop a learning plan for the e-learning product. The project has been put on hold due to budgetary cut backs.

Future Plans 2006-2007

Project/Workload Management:

• Continue to deliver bi-monthly reports, monthly forum and improve reporting as schedule permits.
  
  
• Continue to develop reporting capabilities with a focus on further automating the reporting process to reduce effort required and enhance reporting accuracy.
  
  
• Pursue the following additional performance indicators:
  • Median time per review cycle (year ie. 2003,2004,2005)
  • Median time to pick up "activate" the NDS review
  • Median time to approval for backlogs
  • Median time to approval for each incoming submission group each year
  • For the incoming submission in 2005, % of NDS received in CTD format
  • Number of NDS' reviewed using the CTD format and CTD format review reports
  • Submissions having project plans
  • Submissions meeting project plan milestones
  • % of projects currently on target
  • % of projects off target (requiring remedial action)
    
    
• Continue to emphasize improved and consistent project management-related processes, such as:
  • Networking with the Common Drug Review (CDR) to facilitate drug access
  • Pre-submission and other submission-related Industry/TPD meetings
  • Internal filing meetings
    
    
• Continue to provide Project Management and MS Project training to new RPM's as they are hired.

Good Guidance Practices:

• Conduct external consultations on the GGP Manual in the first half of 2006-2007, followed by implementation of the GGP Manual in the third quarter of 2006-2007.
• Develop guidances using the draft GGP Manual, and follow up with evaluation and possible modifications to the manual as needed.
• Conduct training on the GGP manual as part of implementation.
• Continue to add ideas for guidance development to the needs assessment list.
• Formally choose guidance pilot projects in the first quarter of 2006-2007.

Good Review Practices:

• Launch of the final version of the Good Review Practices Intranet.
• Routinely update Intranet on an ongoing basis.
• Finalize pharmaceutical safety and efficacy assessment templates and SOP.
• Finalize executive summary template and SOP.
• Finalize clinical trial application safety and efficacy assessment templates and SOP.
• Begin work on Reviewer Orientation and Training Program.

Transparency:

Summary Basis of Decision:

• Continue to implement phase I of initiative, drafting SBDs for drugs, medical devices and biologics within the scope of phase I.
• Initiate evaluation of phase I in either in the third or fourth quarter of fiscal 2006-2007. This will include and evaluation of infrastructure, anticipated submissions, resource requirements and feedback received on phase I of the initiative.
• Analyze consultations required to support expansion of the SBD initiative into phase II.

Product Monograph:

• Initiate evaluation of PM implementation during the first quarter of 2006-2007.
• Finalize and distribute the PM public availability Issue Analysis Summary to HPFB for internal consultation during the second quarter of 2006-2007.
• Engage in external consultations during the third quarter of 2006-2007.
• Develop a preliminary resource assessment based on comments and feedback for implementation of the Public Availability of the Product Monograph.

E- Review

• Acquire and implement the long-term viewing tool.
• Continue to enhance and support the interim viewing tool for eCDT paper co-submission and Hybrid filing formats until the long-term tool is in place.
• Continue to provide ECTD technical support for ECTD paper co-submission and Hybrid filing formats
• Release the production roll-out of the Special Access Program for TPD
• Release the production roll-out of the Clinical Trials Adverse Drug Reaction for TPD and BGTD

Enhanced Review Capacity:

• Finalize the development of the on-line database and launch when completed
• Develop user training module and finalize other documents for process training to TPD users
• Establish mailout schedule for current lists of potential applicants
• Develop Outreach Strategy to include contact with medical organizations, institutes, etc in a planned manner
• Use of SIMS tool to further enhance marketing activities and outreach
• Investigate upgrades to database system and build enhancements as required
• Track and report on database functionality and contracting activities.

International Regulatory Cooperation:

• Present TPD's IRC strategy to DMC on May 11, 2006 and finalize in June.
• Re-work inventory of activities into a database format. Major projects will be described in the annex to the TPD IRC strategy and will be reviewed on an annual basis.
• Develop a HPFB SOP under the MOU implementation plan for the exchange, documentation, protection, use and monitoring of information. A policy forum for Senior Management in the FDA and HPFB is planned for the fall.
• Continue to deliver training as needed within TPD on good inter-agency practices regarding communication and confidentiality issues stemming from the signing of MOUs.
• A retrospective review of drugs reviewed by both jurisdictions with a view to better understanding similarities and differences in risk assessment and decision making will move forward in 2006, beginning with the analysis of one drug reviewed and approved by both jurisdictions.
• Update and finalize the framework for Cooperation on Product Quality in May 2006.
• Participate in the first CMC reviewers discussion forum on May 23rd and 24th in Washington. A second forum may be planned for early 2006.
• Attend potential training session offered by ONDC the process analytical technology (PAT) guidance for reviewers. This training is expected to move forward during the summer of 2006.
• Pursue a pilot project with CDER on real-time dialogue during the course of product review as a potential step towards a more formalized arrangement.
• Update and finalize the framework for Cooperation on Medical Devices in August 2006.
• Identify Registrars/Auditing Organizations to participate in the CDRH-medical devices project. The first pilot audit is targeted to take place during the winter of 2006-2007.
• Host a potential HPFB-FDA senior officials meeting in Ottawa, which is tentatively scheduled for fall of 2006.
• Participate in discussions to be held following the ICH meetings in June 2006 on more formalized cooperation between TPD/HPFB and the European Commission/EMEA.
• Prepare a final report on the comparative review of TPD and EDQM reviews in June 2006. Final recommendations on the use of the EDQM CEP in Canada are to be developed and presented to senior management in the fall.
• Continue to send TPD staff to the EDQM to participate in CEP reviews.
• Finalize the TPD-EDQM MOU and confidentiality arrangement in the summer of 2006.
• Participate in the next HPFB-SFDA Senior Officials meeting in Beijing during June 2006.
• Continue to test solutions and complete administrative policies for the confidence building exercise (CBE) so that the acceptance of respective certificates may come into effect prior to the formation of the new Trans Tasman agency. This is a complex resource intensive project that will require the development of policies, guidances, procedures and communication strategy in addition to the MOU and execution of the CBE within the framework of five parallel projects.
• Finalize framework, guidance and SOP for foreign reviews by the end of 2006.

International Harmonization:

• HPFB will continue to participate in all ICH-related activities in the next fiscal year. The next meetings will take place in Yokohama in June 2006; in Chicago, USA in November 2006; and in Vienna Austria in March 2007.
• Finalize training and capacity building strategy in June 2006 and proceed with the development of RHI profiles.
• Engage in further discussions on the future of ICH and work with the FDA to develop a proposal on how to make more effective use of the Regulators meeting.
• Post draft Health Canada question and answer document regarding ICH S7B and E14 guidances. Draft guidance for industry regarding QT/QTc Interval Prolongation on guidance for Product Monograph content and for analysis and review of QT/QTc interval data in June 2006.
• 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. This includes coordinated activities for medical devices and drugs (including medicinal plants), the latter of which is coordinated through the Pan-American Network on Drug Regulatory Harmonization (PANDRH).
• TPD and ORIA continue working with the International Affairs Directorate to secure longer term funding for PANDRH/PAHO activities through the Bi-ennial Program Budget fund. 
• Continue to participate in US Pharmacopoeias Participation and European Pharmacopoeias Commission working groups that involve setting standards, methodologies and monographs.

Change Management

Communication Products:

• TPD News will continue to be produced quarterly.

Training:

Design, develop and deliver the following training programs:

• Customized PDP Training delivered to all TPD Managers and all other staff
• Competency Based Management Development Training Program to all TPD managers and possibly supervisors
• Competency Based Project Management Training Program