Therapeutic Products Directorate
Business Transformation
Progress Report 2003-2004

Date: 2006-02-08

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Table of Contents

Message From the Director General

Who We Are

• TPD Vision
• TPD Mission
• Our Organization
• Health Canada's Therapeutics Access Strategy
• Business Transformation Strategy
• Office of Business Transformation
• Performance Measurement Framework

Our Results

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

Future Plans

• This Year: 2004-05
• Project Management
• Good Guidance Practices
• Good Review Practices
• Enhanced Review Capacity
• International Regulatory Cooperation
• International Harmonization
• E-Review
• Transparency: Summary Basis of Decision
• Transparency: Product Monograph
• Change Management
• Moving Forward

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Message From the Director General

It is an exciting and innovative time to be working at Health Canada and the Therapeutic Products Directorate (TPD). For the past two years, through the excellent work of the Core Engagement Team andBusiness Transformation Project Leaders, TPD has been at the forefront of the process to bring leadership, clarity, and accountability to the way we do business. The commitments we have made are ambitious. The resource investments needed to support them are significant, but so are the results that we have delivered.

The work of TPD builds on the commitments made by the Government of Canada to "speed up the regulatory process for drug approvals," to move forward with a smart regulation strategy to accelerate reforms in key areas to promote health and sustainability, to contribute to innovation and economic growth, and to reduce theadministrative burden on business.

In this first Business Transformation Progress Report, we describe in some detail not only the nature of the work we undertook during the past year, but also the results we achieved. We are proud of these accomplishments, and we look forward to continuing and expanding on them in the future.

I applaud the hard work and dedication of all staff to bring about the changes to deliver on the Government of Canada's commitment to Canadians.

It is with pleasure that I present to you the first TPD Business Transformation Progress Report, and I invite you to share in our successes.

Dr. Robert Peterson
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 thatcontribute to the regulatory review process are accomplished through the dedicated work ofmore than 400 employees.

The following bureaux comprise TPD:

• Bureau of Metabolism, Oncology and Reproductive Sciences
• Bureau of Gastroenterology, Infection and Viral Diseases
• Bureau of Cardiology, Allergy and Neurological Sciences
• Bureau of Pharmaceutical Sciences
• Senior Medical Advisor Bureau
• Medical Devices Bureau
• Office of Patented Medicines and Liaison
• Bureau of Operational Services
• Policy Bureau
• Office of Business Transformation

TPD Vision

TPD makes a major contribution 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 assessing the safety, efficacy, and quality of pharmaceuticals and medical devices in a timely manner

Our Organization

THERAPEUTIC PRODUCTS DIRECTORATE
Structure effective December 1, 2003

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 thesafe 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 2003 provided $190 million over five years to improve the timeliness of Health Canada's regulatory processes with respect to human drugs while preserving the principle thatsafety 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:

• transforming the regulatory performance by improving the timeliness and transparency of thereview process for therapeutic products while maintaining Health Canada's high standards for safety;
• enhancing post-market surveillance by exercising greater vigilance around safety and therapeutic effectiveness issues once products reach the market; and
• 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 TAS, is to deliver on the government's commitment and to position TPD as a contemporary regulator.

Specifically, strategic planning work in 2001 identified 12 strategic initiatives, which provided a foundation for TPD's Business Transformation Strategy. In fact, three of the initiatives (Project Management Approach to Review, Good Review Practices, and Summary Basis of Decision) are making key contributions to the Health Products and Food Branch (HPFB) in terms of meeting TAS objectives and, as such, are TAS-funded initiatives. They also align with HPFB's strategic objectives.

TPD is committed to delivering on eight identified initiatives to move TAS forward and meet estab- lished 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

Office of Business Transformation

The Office of Business Transformation (OBT) was created in May 2003 to coordinate and provide leadership to accomplish the Business Transformation Strategy objectives. A division has been estab- lished within OBT to monitor, track, and report on the progress and performance of each initiative, aswell as to support the business transformation planning process and evaluation activities.

A business transformation/TAS project leaders group has also been formed. Regular meetings are held with the TAS project leads to share information, address common issues, and create common linkages between initiatives. Several successful meetings have taken place with representatives from this group providing information and updates to senior managers, middle managers, and all TPD staff.

Performance Measurement Framework

A Results-Based Management and Accountability Framework (RMAF) for TAS Track I was designed by the TAS Secretariat and includes a logic model, performance measurement and reporting strategy, performance indicators, and ongoing measurement strategy for TAS implementation.

To meet the performance measurement requirements of the TAS Secretariat, OBT has taken the initiative in developing a detailed business transformation performance measurement framework. This framework will help respond to TAS inquiries, as well as provide important information not only on the current status of the ongoing projects, but also on the qualitative issues. Each initiative will be measured in the short term to ensure that it is meeting the identified milestones and deliverables. In the long term, these initiatives will be examined to see if they are having the desired outcomes and impacts as stated in TAS. With timely analysis, we will be able to investigate our successes and failures and make adjustments accordingly. Our goal is to be able to attribute success in specific areas, as well as account for the funds provided to accomplish our goals.

Our Results

Over the first year two main priorities have been met. The first of the two priorities includes the development of initiatives to better manage the workload and reduce the backlog of new drug submissions. The second priority involves investments in the foundation necessary for achieving sustained improvements in pre-market regulatory performance and real-world safety and access over the longer term.

Project Management

The Project Management Initiative is led by OBT. Project management is expected to generate improvements in the review process in order for review teams to 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 thecompletion of reviews within performance targets. The intended outcome of project manage- ment is to achieve high quality reviews and reports within performance targets. The project management approach will ensure that appropriate review targets are set and monitored for each submission/application; that 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 following details some specific achievements of the Project Management Initiative.

• Largely as a result of the changes implemented over the first year of TAS, TPD has managed toeliminate 62 percent of the backlog for pharmaceutical submissions and 75 percent of the backlog for medical device licences. This will allow for an increasing proportion of reviews tobe completed within performance targets in the second year of TAS. The introduction of project management philosophy, training tools, extended hours, and review contracts have allbeen contributing success factors.
• TPD has created new positions for regulatory project managers and run competitions over the past several months, completing the competitive process in February 2004. By the 2004-05 year-end, TPD expects to have hired 16 regulatory project managers who will be responsible forcoordinating and guiding each submission through the entire review process.
• A Regulatory Project Management Division has been created within TPD's Office of Business Transformation, consisting of an acting manager, senior advisor, and five senior regulatory project managers (each assigned to provide services to a review bureau). There are currently sixsubmission processing clerks with two new positions to be staffed over 2004-05.
• TPD has introduced project management principles for effective coordination of the review process, which are expected to optimize the transparency, efficiency and timeliness of the review. Other HPFB directorates, such as Biologics and Genetic Therapies Directorate (BGTD) and Natural Health Products Directorate (NHPD), have also implemented a project management approach.
• The Competency-Based Project Management Training Program provides all TPD and BGTD staff with the opportunity to participate in a three-day project management training course. This approach to course participation aims to facilitate the team approach to work. TPD has promoted the program with a series of communications products and events, including a "Meet the Trainer Session," posters, pamphlets, and participation charts. A project management training schedule was organized for all staff of BGTD between March and May 2004. By the fall of 2004, all TPD staff will have had a training opportunity. TPD has shared its efforts andthe Competency-Based Project Management Training Program with BGTD, Corporate Services Branch (CSB), and the U.S. Food and Drug Administration's Center for Devices and Radiological Health (FDA-CDRH).

Good Guidance Practices

The Good Guidance Practices (GGP) initiative will create a common process for developing all documents that provide guidance to staff and stakeholders. GGP will ensure that all internal and external guidances are fully supported by our regulatory framework and international obligations, and are written in a consistent format with suitable language. The following outlines some of the achievements of the GGP initiative.

• A TPD/BGTD Good Guidance Practices Working Group has been formed and its terms ofreference and action plan have been drafted. The goal of this group is to develop a GGP Framework and complete a guidance needs assessment.
• A definition of guidance has been developed. Roles, responsibilities, and principles for guidances and guidance development have been drafted.
• A process map for guidance development has been drafted and is being reviewed by the working group. A standard operating procedure for guidance development is being drafted.
• Via the GGP Working Group, an inventory is being created and will be finalized in 2004-05. The inventory will be used to identify and prioritize guidances needing revision and new guidances to be developed under the new GGP framework.

Good Review Practices

Good Review Practices are review standards (such as guidances, standard operating procedures, and templates) designed to ensure the timeliness, predictability, consistency, and high quality ofreviews and review reports. The Good Review Practices Initiative is an umbrella under which review standards are the sub-projects. The initiative will establish review standards based on information gained regarding internal and external best practices. The following are some of theresults achieved under this initiative.

• TPD created a cross-bureau steering committee (includes BGTD, NHPD, and Veterinary Drugs Directorate) to lead the development of Good Review Practices.
• TPD hosted a Regulatory Risk Management Workshop in spring 2003, which emphasized theimportance of the consistent application of regulatory decisions. The workshop focussed on the legal foundation of the regulatory process and the need to follow due process in the application of regulations.
• The workshop identified key components that are now being developed under the Good Review Practices framework. The key sub-elements of the framework that have been developed include a review template and a standard operating procedure.
• TPD and BGTD have developed review templates for clinical and quality components in accordance with common technical document (CTD) specifications and as part of the Good Review Practices project. The review templates encourage greater consistency in the review process and the review report. In order to meet the July 1, 2003 CTD implementation date, anew guidance package was prepared and posted on the TPD and BGTD web sites enabling the appropriate use of the CTD format to be extended to most types of drug submissions filedin Canada.

Enhanced Review Capacity

This initiative involves building internal capacity and the appropriate use of expert advice from external sources, such as drug or disease experts, professional associations, scientific advisory panels, and academic institutions. One of the goals of the Enhanced Review Capacity Initiative isto identify a pool of experts with scientific knowledge who could be called upon to support and supplement internal review expertise. This will enable TPD to continue to meet its performance goals as the workload related to submissions increases or decreases. Strategies to enhance scientific review capacity include the following:

• hiring additional residential reviewers;
• contracting external science expertise;
• establishing additional scientific advisory committees/scientific advisory panels; and
• exploring institutional capacity (medical schools, hospitals, research institutions).

The following describes some specific achievements of this initiative.

• To enhance the science, quality, and credibility of regulatory decisions, TPD has created four new scientific advisory committees: Human Reproductive Therapies, Anti-Infective Therapies, Medical Devices in the Cardiovascular System, and Oncology Therapies. Two new scientific advisory panels, Hepato-toxicity and Selective Serotonin Reuptake Inhibitors, have also been established.
• TPD is participating in a departmental global procurement pilot. This pilot involves examination of the contracting procedure and targeted recruitment of external scientific expertise. The outcomes of the pilot will provide TPD with recommended approaches for the development ofan appropriate contracting model. This model, which will be used to inform the strategy forengaging external expertise, will also be aligned with performance standards and will complement succession planning.
• TPD has undertaken an initiative to review the contract requisition process from inception in TPD to approval by Corporate Services Branch. The review will result in a standard operating procedure to help identify and meet contracting needs. The process is also intended to help TPD develop business process maps with activity descriptions of the contract review and approval process, to clarify roles and responsibilities, and to identify training needs to ensure that the process and its participants are as effective and efficient as possible.
• TPD has identified overtime as a short-term workload management solution to meeting backlog reduction commitments. In October 2003, TPD conducted a brief survey on the use of overtime. The survey, which was intended to provide the Directorate with an understanding of overtime usage, provided a foundation for the development of an overtime guidance to ensure that managers had the information required to arrive at operational decisions on the use of overtime.
• Other forums have been used to explore potential sources of new expertise. In January 2004, TPD organized a meeting with the Canadian Society for Clinical Pharmacology and the Canadian Association for Population Therapeutics. The purpose was to establish greater linkages with the academic community by selecting appropriate members to participate in scientific advisory bodies. In February, TPD met with the Deans of Pharmacy to discuss potential opportunities for recruitment, including the development of university curriculums to encompass more student work-study programs, as well as new course material to further develop the skills required to conduct scientific reviews. Based on the high level of interest demonstrated by both parties, future discussions are to take place.

International Regulatory Cooperation/Harmonization

International Regulatory Cooperation (IRC) involves the development and strengthening of relations with other regulatory authorities and with international health organizations to provide for a more effective, efficient and informed domestic regulatory program. IRC also includes initiatives designed to improve the regulatory capacity of developing countries and emerging economies. IRC activities may take place within a bilateral or multilateral context, guided by a cohesive international strategy to help ensure optimal benefit from invested resources.

Harmonization 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 outlines some specific achievements under this initiative.

• HPFB has been making great progress in establishing the guidelines and infrastructure required to move forward with international harmonization initiatives. Through participation with the International Conference on Harmonization (ICH), it is now possible to accept submissions prepared in accordance with the CTD, a common format for filing applications in the United States, Europe, and Japan. The CTD may lead to a greater number of simultaneous marketing applications among ICH participants. It may also support earlier access to new therapies that may not have been available in Canada until months or years later after market launches in largely populated jurisdictions such as the United States.
• HPFB has been working with colleagues in other jurisdictions to identify opportunities for cooperation. In November 2003, Health Canada and the U.S. Food and Drug Administration (FDA) signed a memorandum of understanding (MOU) regarding the sharing and exchange of information about therapeutic products, allowing for greater collaboration on shared priorities. An MOU was recently created with Australia's Therapeutic Goods Administration during its visit with HPFB in April 2004.
• TPD formalized a visiting experts program with the European Medicines Evaluation Agency (EMEA). Through this program, Health Canada review staff have an opportunity to observe the European centralized procedure and corresponding function of the EMEA as a coordinating body. This has already provided Health Canada with a glimpse of European best practices, as well as similarities and differences in approaches. Through contacts that were established as a result of a senior evaluator's extended visit with the EMEA, a scientific administrator came to speak at a Health Canada learning event in March 2004 on the use of good review practices atthe EMEA.

E-Review

The E-Review Initiative is designing, developing and implementing a system to accept electronic submission/application documentation from industry to provide automated work flow and immediate access to product-related information over a product's life cycle.

By September 2004, HPFB will be ready to receive and process electronic applications in theCTDformat. Having the capacity to accept the CTD electronically (e-CTD) will introduce greater efficiency to the review process. Although this is a Branch-led initiative, TPD does haverepresentation along with other directorates implicated in the initiative.

Transparency

This initiative aims to strengthen Health Canada's position as a transparent regulatory authority and to provide improved information to Canadians about the benefits and risks of therapeutic products. Specifically, transparent review decisions by Health Canada will provide health care professionals and patients with more information to make informed treatment choices.

Two major transparency projects involve the development of publicly available product monographs¹, written in a plain-language format for use by patients and health professionals, and the development of documents to be made available to the public, which will provide a summary of the basis for the Department's regulatory decisions.

The Product Monograph Project involves two main activities:

• revising the format and content of the product monograph; and
• developing an implementation plan for the dissemination of the product monograph.

The revised product monograph guidance document and templates were developed to provide sponsors with directions for creating a product monograph that better meets the needs of health professionals and consumers. The product monograph guidance document and templates were published on October 1, 2003, and are being implemented through a phased-in approach. The following details some specific achievements under this initiative.

• Over the past year, new initiatives involving transparency have been undertaken, and mature transparency projects have further evolved. In October 2003, the final version of the revised product monograph guidance document (complete with standard product monograph template) was released. The revised guidance is presented in a language and format that are appropriate for the intended audience, divided into the following three distinct sections: health professional information; scientific information and consumer information. The new format is expected to help the consumer understand what the medication is, how to use it, and what the potential side effects are.
• The Product Monograph Project will include policy development to examine the requirements for making the product monographs publicly available. A pilot is currently under way to post product monographs on HPFB's drug product database. This new functionality provides TPD staff with access to product monographs. Eventually, this functionality will provide review staff with a valuable resource that can aid in the review of new applications, support greater consis- tency in labelling, and provide an efficient mechanism for searching product monographs.
• The internal pilot will determine the feasibility of an external launch of product monographs either by Health Canada or by a third party. It will also aid in the assessment of costs (in terms of time and resources) involved in posting and maintaining the product monographs.

The Summary Basis of Decision Initiative is a joint TPD/BGTD project, led by the Policy Bureau ofTPD. The goal of the initiative is to develop and implement a process to publish documents forpublic consumption that summarize and explain product-specific regulatory decisions. The documents will include regulatory, safety, efficacy, and quality considerations.

• Summary Basis of Decision is a new transparency initiative. Pilot exercises have begun incor- porating the use of a template Summary Basis of Decision, which provides a summary of the scientific basis on which approval of a specific product is granted. At the end of March 2004, aNotice of Intent was posted on Health Canada's web site, outlining the initiative. Two of the pilot products were published on TPD's and BGTD's web sites on May 14, 2004.

¹ Product monographs are factual, scientific documents that describe the properties, claims, indications and conditions of use of the drug product, as well as other information that may be required for the optimal, safe and effective use of the drug. Currently, drug product monographs are unavailable to the public. However, they can be accessed from the pharmaceutical company or from Health Canada, through Access to Information.

Change Management

The Change Management Initiative is led by TPD's Office of Business Transformation. Change management refers to how an organization prepares for, 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 details some specific achievements under this initiative.

• Change management initiatives, led through OBT, have served to provide the appropriate infrastructure and capacity necessary for achieving sustained improvement in pre-market regulatory performance.
• TPD has launched an internal communications tool, TPD News, published on a bimonthly basis to communicate progress on new and ongoing initiatives. A baseline communications survey (conducted in fall 2003) and accompanying analysis are additional tools to measure the impact of change, as well as the opportunities and challenges posed by TPD's Business Transformation Strategy. A follow-up survey is planned for fall 2004.
• The October 2003 extended management retreat, "Moving Together Towards Project Management," and November 2003 all-staff meeting, "Becoming a Contemporary Regulator," were engagement forums to stimulate dialogue with staff on the changes under way. Various learning events have also served as valuable change management interventions. The Competency-Based Project Management Training Program is one example of this.
• The Project Management Training Community of Practice initiative is designed to share TPD's learning with other organizations. This has enabled TPD to partner with BGTD in evaluating the responses to the request for proposals issued to secure a contractor to deliver the training program. This has also allowed for the sharing of the staff participation strategy and commu- nications toolkit. Other parties that have expressed an interest in the program include the Centrefor Devices and Radiological Health of the U.S. FDA and Health Canada's Corporate Services Branch.

Future Plans

This Year: 2004-05

The first objective of TAS is to improve regulatory performance, including timeliness and trans- parency, benchmarked against leading international practices while maintaining Health Canada's high standards of safety. Through investments and further progress, Health Canada is expected to be able to meet performance targets 90 percent of the time by 2005-06 for pharmaceutical companies' new drug submissions and by 2006-07 for biologics and genetic therapies, including clearing the backlog.

For the 2004-05 fiscal year, the various business transformation initiatives have planned the activities outlined below.

Project Management

• Train new regulatory project managers (RPM).
• Staff remaining positions in Regulatory Project Management Division.
• Improve RPM infrastructure.
  • Develop RPM toolkit.
  • Develop local area network (LAN) structure.
  • Develop RPM workbook, (i.e., reference source).
• Continue to establish review plans.
• Continue with process improvements.
  • Hold Notifiable Change workshop (June 2004).
• Continue with enhanced reporting.
  • Establish a consistent schedule/frequency of reporting.
• Enhance communication to stakeholders.

Good Guidance Practices

• Finalize and consult (internally and externally) on the standard operating procedure for guidance development.
• Complete inventory and conduct a needs assessment (internally and externally).
• Use pilots and possibly modify the standard operating procedure.
• Develop implementation plan.
• Develop training plan.

Good Review Practices

• Prepare project charter, terms of reference, and action plan (TPD GRP Steering Committee: firstquarter of 2004-05).
• Hold half-day brainstorming sessions with staff to collect ideas for GRP sub-projects (May2004).
• Develop first draft of standard operating procedure on conducting drug safety and efficacy reviews (first quarter of 2004-05).
• Develop new draft of template for drug safety and efficacy review reports to replace the Pre-clinical and Clinical Evaluation Report Template (first quarter of 2004-05).
• Provide legal information session for review staff (April 2004).
• Undertake appeals analysis (first quarter of 2004-05).

Enhanced Review Capacity

• Develop and implement a global procurement strategy (departmental initiative: TPD Pilot Group) and a procurement strategy for external scientific experts.
• Enhance contracting infrastructure (e.g., develop document toolkit, customized contract training; evaluate contracting business models and implementation).
• Continue with process improvements.
• Initiate change management interventions to support the procurement strategies.
• Proceed with the request for proposals to establish a national inventory of scientific experts.
• Enhance communication to TPD users.
• Develop scientific advisory committees (SACs) and scientific advisory panels (SAPs), as required.
  • SAC Neurological Therapies.
  • SAC Respiratory Disease Therapies.
  • SAC Cardiovascular Disease Therapies.
  • SAC Metabolic and Musculo-skeletal Therapies.
  • Establish further panels, as needed.
• Evaluate existing scientific advisory bodies.

International Regulatory Cooperation

• Finalize TPD's International Strategy and Inventory of International Activities.
• Transfer guidance document on the use of international reviews to OBT for implementation.
• U.S. FDA: Further develop action plan around MOU; further collaborate with the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health.
• EMEA/European Union: Continue with Visiting Experts Program; begin on-site visit to European Directorate for the Quality of Medicines; explore potential for MOU with EMEA.
• China's State Food and Drug Administration (SFDA): Participate in SFDA-HPFB steering committee meeting (Beijing); participate in senior officials meeting in Hong Kong to discuss generics, bioequivalence, and safety reporting for traditional medicines; deliver workshop in China on quality (TPD official).
• Request visits to other leading agencies (in Sweden, France and Ireland).
• Continue with foreign delegation visits to Health Canada.

International Harmonization

Continued participation in all International Conference on Harmonization activities

• Help to define vision, mission, and work plan for collaboration with representatives from other non-ICH harmonization bodies, as co-chair of the Global Cooperation Group.
• Complete important new guidances on pharmacovigilance planning and QT prolongation; release drafts on pharmaceutical development and risk management.

Continued participation in Pan American Network for Drug Regulatory Harmonization

• Continue working toward complete list of comparator drug products in Americas.

Ongoing work with other international groups

• Work on setting standards, methodologies and monographs, and collaborate on research projects.
• Participate to a greater extent in the expert committees of U.S. and European Pharmacopoeias.

E-Review

• Complete pilot project for SAP and Clinical Trial-Adverse Drug Reaction (CT-ADR).
• Obtain e-CTD submission acceptance (September 1, 2004).
  • Guidance posting (May 14, 2004).
  • People, process and technology readiness efforts under way, coordinating with OBT.
  • Progress toward hybrid e-CTD solution.
• Identify and adopt the longer-term solution.
• Ensure that the regulatory change process is under way for e-signatures.
• Ensure that the security/privacy IT plan is in place.
• Implement internal and external communications strategy.

Transparency: Summary Basis of Decision

• Consult with affected stakeholders (second and third quarters of 2004-05).
• Draft Summary Basis of Decisions (scientific writers: second and third quarters of 2004-05).
• Explore measures to alleviate burden on reviewers (second and third quarters of 2004-05).
• Develop a standard operating procedure to capture procedural and logistical requirements (second and third quarters of 2004-05).
• Develop an implementation plan to examine the infrastructure, resource, and training requirements necessary for effective implementation and sustainability of the initiative (secondand third quarters of 2004-05).
• Implement Phase I for New Drug Submissions for New Active Substances and a subset ofClassIV submissions (third quarter of 2004-05).
• Conduct a 6 to 12 month evaluation after the implementation of Phase II (second and thirdquarters of 2004-05).

Transparency: Product Monograph

Generating potential solutions(April-December 2004)

• Develop option paper for stakeholder consultation.
• Conduct internal and external consultation on option paper.

Selecting and planning the solution(January-March 2005)

• Develop final plan for the posting of product monographs.
• Develop internal standard operating procedures for the posting.
• Revise affected guidance documents (Management of Drug Submission Guidance).

Implementing the solution(April 1, 2005)

• Post the product monographs.

Change Management

Events

• Conduct Change Survey (Fall 2004).
• Work on concept development for a project management certification program.

Communications

• Produce TPD News.
• Develop TPD Fact Sheets.
• Write TPD Progress Reports.

Training

• Offer advanced project management training.
• Provide Microsoft Project training.
• Continue to build a community of practice: participation of the U.S. Food and Drug Administration's Center for Devices and Radiological Health in TPD competency-based project management training course(s).

Moving Forward

In the second year of TAS, the package of business improvement activities will be further enhanced. This includes project management, e-review, the use of external review expertise, and greater science capacity. Health Canada will continue to move forward in building the necessary infrastructure for a comprehensive post-market regime. A strategy on international regulatory cooperation will be produced.

Transparency and stakeholder engagement will continue to be an area of major focus. Greater risk communications and information for consumers are methods by which this will be supported.

Planning for the longer-term implementation of the full scope of TAS will be undertaken. This includes policy work on options for strengthening regulatory performance and optimal drug therapy, consultations, the development of a new external charging regime, and the development of proposals to ensure sustainable regulatory performance for human drugs and other therapeutic products.