Therapeutic Products Directorate - Business Transformation - Progress Report 2004 - 2005

Date: 2006-02-08

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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
Office of Business Transformation
Performance Measurement Framework

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 2005-2006

Project Management/Workload Management
Good Guidance Practices
Good Review Practices
Transparency - Product Monograph
Transparency - Summary Basis of Decision
E-Review
Enhanced Review Capacity
International Regulatory Cooperation
International Harmonization
Change Management

Message from the Director General

This has been a remarkable year at Health Canada and the Therapeutic Products Directorate (TPD). TPD continues to make great strides to meet the Government of Canada's commitment to "speed up the regulatory process for drug approvals," and move forward with a smart regulation strategy that will accelerate reforms in key areas to promote health and sustainability, to contribute to innovation and economic growth, and to reduce the administrative burden on business. The work that TPD is undertaking is not only an investment in building a better regulatory system, but a commitment to improving quality of life for Canadians, and building a better future for health care in Canada.

This second Business Transformation Progress Report describes the nature and scope of the work we undertook and the results that we have achieved.We are proud of our accomplishments, and look forward to continuing on this path of excellence.

I would like to acknowledge the tremendous work of former Director General Dr. Robert Peterson in helping to move forward the work on improving the regulatory process for drug approvals. He has our appreciation and gratitude.

Moreover, I would like to take this opportunity to thank TPD staff, who have overcome many challenges to get the work done. A tremendous collective effort at TPD resulted in a backlog reduction of 89 per cent for drugs and significant progress towards review on time especially related to Medical Devices where 62 per cent of Class III and IV and 47 per cent of Class II applications are within performance targets. I commend you for your professionalism, your dedication, and for your grace under pressure. I am proud to say this Directorate has seized the opportunity to build on a strong foundation, and is confidently moving forward with renewed energy to meet the many challenges ahead.

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

Omer Boudreau
Director General
Therapeutic Products Directorate

Who We Are

The Therapeutic Products Directorate 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
• 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
• Submission and Information Policy Division
• 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.

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 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 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:

• transforming regulatory performance by improving the timeliness and transparency of the review 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 established goals with the dedicated funds provided to this end. The following are the eight initiatives:

• Project/Workload 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 established within OBT to monitor, track, and report on the progress and performance of each initiative, as well as to support the business transformation planning process and evaluation activities.

A business transformation/TAS project leaders group has also been formed.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 management 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

Project/Workload Management

The Project Management Initiative is expected to generate improvements in the review process for review teams to operate in a more effective and efficient manner. Through project management approaches, product submissions are managed as projects with the necessary planning, coordination, and management of activities to oversee the completion of reviews within performance targets. The intended outcome of project management is to achieve high quality reviews and reports within performance targets. The project management approach ensures that appropriate review targets are set and monitored for each submission/application; 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 submision/application, and will be responsible for communicating its progress, both internally and externally.

The Workload Management Initiative manages 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 current backlog at any given time.

The following details some specific achievements of the Project/Workload Management Initiative.

• For brand name pharmaceuticals, TPD reached a backlog reduction of 88 per cent by March 31st, 2005. Furthermore, a 91 per cent backlog reduction was achieved for generics and 100 per cent for over-the-counter new drugs. An overall backlog reduction of 89 per cent was reached for TPD.
  
  
• In the area of Medical Devices, 62 per cent of Class III and IV applications are within performance targets and 47 per cent of Class II applications are within the 15 day target.
  
  
• TPD is aggressively managing the submission/application workload. Monthly reports to the Directorate Management Committee highlight both the achievements and workload challenges that each Bureau faces. Periodically, a more detailed report is provided to report performance at the divisional level. This 'accounting' on a monthly basis highlights the number of decisions needed to meet the interim goals established and has been successful in focussing the bureaus efforts.
  
  
• In addition to the monthly reporting, the Senior Regulatory Project Managers (SRPM) and Regulatory Project Managers (RPM) frequently update individual Bureau Management teams and review teams on the progress of specific submissions. This continued emphasis on progress and performance supports proactive management of the submission and submission issues.
  
  
• All the SRPMs/RPMs vacancies have been filled with new staff starting in May 2005.
  
  
• Positive feedback has been received both internally as well as externally from industry regarding interactions with RPMs. External clients have found it extremely useful to liaise with TPD RPMs regarding their various submissions. They have also observed a link between the use of RPMs and the more timely completion of submission reviews.
  
  
• A RPM training program was developed that encompasses 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. This training is being provided to the RPMs on-the-job via one-on-one training by the Senior Regulatory Project Managers (SRPMs), as well as jobrelated training sessions for the RPMs as a group. It is expected that the provision of general training to the RPMs will be completed by September 2005, which is 1.5 years following their hiring.
  
  
• One hundred percent of RPM employees have attended the Competency-Based Project Management Training Program intended for all TPD employees. As new RPMs are hired (e.g. staff replacement), they will receive the Project Management training. Additional Project Management training focusing on soft-skill development was delivered to all RPMs from January to March 2005.
  
  
• One hundred percent of RPM employees have received MS Project training. As new RPMs are hired, they too will receive the training. All RPMs have MS Project installed 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. Submission Review plans were created for the existing workload. As submissions are received, review plans are created. This is an ongoing activity.

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.

• Standard Operating Procedures (SOPs) for issue analysis and guidance development were drafted and it was decided to create a GGP Manual. In addition to the SOPs, components of the Manual (including templates and a style guide) have been drafted and are under review.
  
  
• Roles and responsibilities for the issue analysis and guidance development processes have been drafted and are under review.
  
  
• A needs assessment was undertaken within the GGP Working Group, building on the existing Metatag database in TPD/BGTD. The inventory contains every document posted on the TPD and BGTD Web sites, plus additional documents providing guidance.
  
  
• Extensive work has been completed on the guidance needs assessment. In the first and second quarters of FY 04/05, many internal sessions were held with TPD and BGTD staff (in conjunction with Good Review Practices) to solicit input. A notice was published on the TPD and BGTD web sites in August 2004 asking stakeholders for input into the needs assessment. From these internal and external consultations, lists were created of areas where guidance is needed, guidances needing revision, and guidances from other jurisdictions to be considered for adoption. The input from both consultations has been collated into a report to be published on the TPD and BGTD Web sites in summer 2005. Prioritization activities are underway.
  
  
• Guidance Pilot Projects will formally commence after the finalization of the guidance framework. However, one guidance document has informally been chosen to pilot the proposed guidance and issue analysis summary templates.
  
  
• One additional GGP resource was hired in TPD's Office of Business Transformation, as of the first quarter of 2004/2005.

Good Review Practices

Good Review Practices (GRP) are review standards (such as guidances, standard operating procedures and templates) designed to ensure the timeliness, predictability, consistency, and high quality of reviews 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 the results achieved under this initiative.

• To obtain suggestions for sub-projects to be undertaken, 13 brainstorming sessions were held with TPD staff on both GRP and GGP. In addition, consultations were conducted with external stakeholders in September and October 2004. A letter requesting input on both the GGP and GRP was sent to industry associations and was posted on the TPD Web site. A report on the consultations will be posted on the TPD Web site.
  
  
• Based on the input received during the brainstorming with staff and from the external consultations, a list of suggested GRP sub-projects was prepared. The Steering Committee developed prioritization criteria and a prioritized list of suggested sub-projects.
  
  
• A draft Standard Operating Procedure (SOP) on how to conduct safety and efficacy reviews of pharmaceutical submissions is currently being prepared and will be piloted in summer 2005.
  
  
• A draft template for the safety and efficacy review of pharmaceutical submissions was issued in May 2004. It is currently being used by TPD safety and efficacy review staff, and will be piloted for a period of one year prior to finalization.
  
  
• An analysis of appeals filed with TPD was initiated by the Senior Medical Advisor Bureau in January 2004, and was brought under the umbrella of the Good Review Practices in March 2004.With the preparation of the report, this sub-project is now complete.

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 monographs, written in a plainlanguage 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.

Product Monograph

The Product Monograph Project involves two main activities: the revision of the format and content of the product monograph; and the development of an implementation plan for the dissemination of the product monograph.

• The revised Product Monograph guidance document, external consultations, training development, and delivery have all been completed on schedule.
  
  
• Health Canada is developing policy and implementation plan to make product monographs publicly accessible. The Department recognizes that there are some important issues that must be addressed prior to the development of this implementation plan. A Discussion Document has been developed to advise stakeholders on issues involved in making the product monograph publicly accessible, and to solicit feedback on the proposed options. External consultation on this Discussion Document is planned for Fall 2005.
  
  
• The Product Monograph Pilot Projects have been completed with more than 1000 product monographs entered into the internal Drug Product Database.

Summary Basis of Decision

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

• Pilot exercises have been conducted with industry stakeholder participation, and in three cases were published to the TPD/BGTD Web site for external consultation purposes (2 drugs/1 medical device). The pilot exercises tested the suitability of the prepared templates using recently approved products and have been revised to reflect feedback obtained through consultation.
  
  
• Numerous internal and external consultations were held to solicit feedback from interested parties. Consultations conducted include a two-day SBD specific workshop (June 2004), presentations to the Public Advisory Committee and the Advisory Committee on Management (September 2004), pilot exercises conducted with external industry and provincial stakeholders,Web site publication of revised templates, and proposals for stakeholder feedback (November 2004). Stakeholders who have participated include representatives from patient groups, consumer associations, industry, health professionals, academia, government, other regulators, and the general public.
  
  
• In addition to the above, numerous communications have been prepared and issued to convey progress to staff and stakeholders and provide clear direction regarding implementation. Phase I has been implemented as of January 1, 2005.
  
  
• Feedback obtained to date from consultation evaluations and discussions indicate overall stakeholder satisfaction with the process, product, and consultation vehicles selected.
  
  
• Three scientific writers were hired in 2004/2005 to ensure the necessary infrastructure to draft the documents in TPD and BGTD.
  
  
• Standard operating procedures for the preparation and publication of SBDs have been developed with input from all affected staff. A notice to stakeholders is being developed to communicate relevant aspects. BGTD and MDB have developed corresponding individual SOPs to satisfy the specific needs of their respective areas.
  
  
• Work has been underway to complete background materials such as the HPFB Backgrounder, a Frequently Asked Questions document, Reader's Guides, and a listing of foreign regulatory jurisdiction Web sites for linking to SBDs. This background information is in direct response to messages gleaned from participants at external consultation venues. All information will be published to the Web sites and linked to SBD prior to publication of the first SBD, anticipated in summer 2005.

Bilateral Meeting Program

TPD's Bilateral Meeting Program (BMP) supports HPFB's key strategy to improve transparency, openness, and accountability to strengthen public trust and stakeholder relationships. TPD and other HPFB Directorates meet regularly with numerous national industry and health care professional associations to discuss and consult on regulatory issues of mutual interest, share information, expertise and, when appropriate, responsibilities.

• An evaluation of TPD's BMP was conducted over the summer of 2004 to measure internal and external satisfaction with the current process and explore options for adopting more effective, efficient, and innovative ways to manage stakeholder group relations. An action plan is being implemented to address recommendations identified through the evaluation, thereby improving the BMP and maintaining its utility.

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.

E-Review activities completed over the course of 2004-2005 included:

• conducting a Privacy Impact Assessment and Threat Risk Analysis;
• the piloting of two systems to automate the Special Access Program and Clinical Trials Adverse Drug Reaction (CT-ADR);
• an Information Technology services delivery re-alignment;
• a detailed functional & IT requirement analysis for the long term end-to-end solution; after structure requirements
• groundwork for defining legal, security, privacy, and infrastructure requirements;
• a request for an amendment to the regulations to accommodate eRecords and eSignature; and
• submissions accepted in the electronic common technical document (eCTD) format in TPD and BGTD (paper co-submission).

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 is to 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 fluctuates. Strategies to enhance scientific review capacity include the following:

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

The following describes some specific achievements of this initiative.

• Therapeutic Class Specific Standing Committees:
  • A Terms of Reference (TOR) was prepared and a full nomination process completed for the Scientific Advisory Committees (SAC) on Neurological Therapies and Metabolic and Endocrine Therapies.
  • A panel has been formed on Neuropathic Pain and a meeting was held in December 2004.
  • A TOR was prepared for the SAC on Musculoskeletal Therapies. A list of nominees has been completed.
  • A TOR was prepared for an Isotretinoin panel and membership solicited.
  • A SAP on Breast Implants was held in March 2005.
  • A SAP on Reprocessing of Medical Devices held their first meeting on February 10-11, 2005.
  • A SAP on NSAIDS teleconference was held on February 7, 2005.
  • A TOR was created for a SAP on Pediatrics.
  • A SAC on Oncology met in March 2005.
  • A meeting of the SAC on Medical Devices (SACMDUCS) used in the Cardiovascular System met in December 2004.
    
    
• As part of TPD's Contracting Strategy it was determined that the best way to recruit qualified scientific expertise would be through a Request for Information (RFI). As a result a RFI was crafted and reviewed. It will be distributed in two phases during the 2005/2006 fiscal year.
  
  
• An Enhanced Review Capacity Unit within OBT was created and staffed comprised of a special advisor, procurement officer, and administrative support. The Unit provides contracting support and training to the Review Bureaus to facilitate the contracting process.
  
  
• Work to create an inventory of scientific experts housed in an ORACLE database is underway. This database will house pre-qualified candidates for future contracting requirements and participation in TPD's SACs/SAPs. The development of a project plan and user requirements are complete. A prototype is currently being developed, and will be tested in the beginning of FY 2005/06. Any necessary revisions will be made prior to a full launch.
  
  
• An Outreach Strategy has been undertaken with several Review Bureaus Directors and other TPD staff, who have provided names and CVs of individuals who may be potential contractors for TPD. These individuals will be provided with the RFI package once it has been finalized.
  
  
• A pilot project was initiated to identify scientific expertise to meet an immediate need with the Bureau of Cardiology, Allergy and Neurological Sciences (BCANS). Names/CV's provided will be added to the expert advisory database which is currently being developed.
  
  
• Customized Statement of Work training was developed to ensure that TPD staff understand the importance of a SOW within the contractual process and can create a SOW that meets the highest standards. A pilot course was held in February 2005.

International Regulatory Cooperation

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.

The 1999 Therapeutic Products Program (TPD predecessor) International Strategy is being updated in order to reflect the current mandate, regulatory environment, and government, department and branch policies and priorities, as well as to ensure that TPD achieves the greatest net benefit from investment in IRC activity.

Cooperation with the U.S. Food and Drug Administration

Work continues with HPFB's Office of Regulatory and International Affairs (ORIA) to finalize the Memorandum of Understanding (MOU) Implementation Plan with the United States Food and Drug Administration (FDA).

Some key areas of TPD involvement with the FDA include:

• Numerous visits and discussions between the Office of New Drug Chemistry, Center for Drug Evaluation and Research (CDER) and TPD over the course of 2004 to study respective regulatory approaches, identify training opportunities, and establish a framework and mechanisms for closer cooperation.
  
  
• TPD is also pursuing cooperative activities with the Centre for Devices and Radiological Health (CDRH), FDA. Meetings in March of 2004 and 2005 explored mechanisms and candidates for cooperation under the HPFB-FDA MOU Implementation Plan. Plans for collaboration in priority topic areas will be developed within a cooperative framework that is also under development.

Cooperation with Europe

• In early 2005, work was completed on a joint HC-European Union (EU) Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products, the first such collaboration between the two regulators. The guideline was made possible as a result of the interest shown by European experts in the TPD draft guidance on the same subject. The European Medicines Agency (EMEA) and the TPD have posted the joint guidance on their Web sites for a six month comment period.
  
  
• Through the Interchange Canada program, an expert from the Irish Medicines Board completed a successful work exchange within the Bureau of Cardiology, Allergy and Neurological Sciences for a period of six months between May 2004 and November 2004. The exchange contributed significantly to the better understanding of European and Canadian drug review systems and best practices.
  
  
• In March of 2005, TPD visited the EMEA to study the agency's Eudravigilance adverse event reporting systems, specifically those in place for handling adverse events (AEs) associated with on-going clinical trials.
  
  
• A pilot project is currently underway to review reports prepared by the European Directorate for the Quality of Medicines (EDQM) in order to decide on official recognition of its Certificate of Suitability (CEP). CEPs are used by manufacturers of pharmaceutical products in their applications for market access, to demonstrate compliance of the substance used with monographs of the European Pharmacopoeia.

Cooperation with the State Food and Drug Administration of China

Cooperation with the Chinese State Food and Drug Administration (SFDA) continues under a Plan of Action originally signed in 1999 and renewed in November 2001. Such cooperation takes place within the context of increasing trade and the strengthening and modernization of the Chinese regulatory system.

• In April of 2004, TPD along with other HPFB directorates hosted visitors from the SFDA for several weeks. The extended visit was an opportunity for SFDA officials to learn about our approaches, standards and policies, and to further ongoing dialogue with Canadian colleagues. An evaluation of the SFDA April 2004 visit to Canada as well as past interactions, ongoing interactions and long term objectives was prepared for discussion at the Joint Senior Officials Meeting (SOM) in Beijing which was attended by senior HPFB officials in October 2004. During the SOM, officials agreed in principle to draft terms of reference and develop draft work plans in the areas of pharmaceutical quality, medical devices and Good Manufacturing Practices/ADR reporting.
  
  
• Joint SFDA-HPFB workshops on medical devices and on pharmaceutical quality/bioequivalence also took place in China following the SOM in November 2004.
  
  
• Development of current year work plans is underway regarding pharmaceutical quality, bioequivalence, clinical trials, and medical devices. Agreed upon priorities and work plans will be confirmed at the next meeting in April 2005, together with the SOM Terms of Reference and a protocol for the exchange of personnel to help promote and evaluate the impact of staff exchanges.

Cooperation with the Therapeutic Goods Administration of Australia

Discussions between the TPD and the Australian Therapeutic Goods Administration (TGA) are ongoing. The objective is to develop an MOU respecting quality systems certificates issued for manufacturers of medical devices. The aim of this collaborative undertaking is to facilitate access to medical devices in each other's markets while maintaining high regulatory standards for these devices.

• Senior officials from the Branch and the TGA met in Ottawa in January 2005 to develop and agree on the processes, procedures and framework required to recognize the quality systems certificates produced under respective regulatory systems. Project and communication plans are being developed.
  
  
• The meetings were successful in promoting a much deeper understanding of respective regulatory systems, developing a project plan and confidence building evaluation approach and reaching consensus on the scope, nature and elements of the MOU. A public statement was also drafted and posted on both TGA and HC Web sites.

International Harmonization

Harmonization refers to the development, adoption, and implementation of international technical standards for the development, registration, and control of pharmaceuticals and medical devices. The following outlines some specific achievements under this initiative.

International Conference on Harmonisation

As coordinator of Health Canada's overall involvement in the International Conference on Harmonisation (ICH), the TPD sits as observer to the ICH Steering Committee and was also asked to co-Chair the ICH Global Cooperation Group (GCG). Steering Committee discussions continued in 2004 around optimizing work practices and improving future operations, transparency, and communication. In recognition of the contribution of observers, Canadian experts will be permitted to sign off on ICH guidelines, as proposed by Health Canada.

Other highlights from 2004.

• The November ICH meetings in Yokohama provided an opportunity to conduct a brainstorming session aimed at identifying important gaps in pharmacovigilance/safety guidances. Suggested topics for consideration were presented by all parties, including Health Canada. The preliminary discussions will lead to further discussion at the May ICH meeting in Brussels, the objective of which is to identify new work in the area of pharmacovigilance. This, together with the completed E2E guidance (Prospective Pharmacovigilance Planning), will have direct implications vis-a-vis the strengthening of patient safety internationally.
  
  
• TPD also led the development of an ICH considerations document on the inclusion of Women in Clinical Trials which was published on the ICH Web site in December 2004.Work will continue with the Women's Bureau on the development of additional statements and definitions on gender/sex considerations in clinical trials, for posting together with the ICH document.
  
  
• In line with its new mandate, GCG held its first meeting with five regional harmonization initiatives with a view to promoting a global understanding of ICH guidances and good harmonization practices, as reflected in a new draft mission statement.
  
  
• The National Placebo Initiative, which was co-sponsored by Health Canada and the Canadian Institutes of Health Research, was recently completed. This Initiative spanned over three years of extensive public and stakeholder consultations. The final report was released in September 2004. Health Canada is in the process of examining the outcomes of all the activities of the National Placebo Initiative and examining options for moving forward.
  
  
• TPD/HPFB participation in and contribution to ICH guidances continues with the development of draft guidances on Pharmaceutical Development (Q8), Quality Risk Management (Q9), Immunotoxicology (S8), and the nonclinical and clinical aspects of QT/QTc Interval Prolongation (S7B/E14), the latter of which evolved from a joint Health Canada-U.S. FDA concept paper. Work also continues on evolving eCTD and electronic standards (M2) and the development of procedures for the regulatory acceptance of pharmacopoeial harmonization (Q4B).

Other Initiatives

• TPD continues to participate in Pan-American activities that promote convergence of systems and standards in order to promote the quality, safety, and efficacy of therapeutic products in the Americas. This includes coordinated activities for medical devices and drugs (including medicinal plants), the latter of which is coordinated through the Pan-American Network on Drug Regulatory Harmonization (PANDRH).
  
  
• TPD has participated on working groups dealing with bioequivalence, drug classification, and initial work on combating drug counterfeiting.
  
  
• A PANDRH Steering Committee meeting was held in December 2004 in Washington to review surveys on bioequivalence and drug registration requirements and other Harmonization outputs and develop the agenda for the Fourth Pan American Conference on Drug Regulatory Harmonization, which took place in March 2005 in the Dominican Republic. The conference represented an important milestone for PANDRH as the initial wave of PANDRH guidances and documents were endorsed by the conference, including GCP, the GMP Inspection guide, a roadmap for combating counterfeit drugs, and the reports of surveys on drug classification and registration. The draft guidance on criteria for bioequivalence and bio-waivers was also discussed.
  
  
• TPD continues to participate in three expert US Pharmacopoeia committees involved in standard setting and drug information and participates as an observer to the European Pharmacopoeia Commission.

Change Management

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.

Communication Products

• The Office of Business Transformation continues its second year producing a quarterly newsletter entitled TPD News to communicate items of interest to TPD staff. Over the course of the year five issues were produced (March-April 2004,May-June 2004, July-August 2004,Winter 2004, and Spring 2005). They were distributed in hard and electronic format to all TPD staff and other key internal and external stakeholders. Additionally, two TPD News Specials were produced.
  
  
• Fact sheets were developed for 12 Strategic Initiatives: Workload Management, Project Management, Good Review Practices, Good Guidance Practices, International Regulatory Cooperation, International Harmonization, E-Review, Summary Basis of Decision, Product Monograph, and Enhanced Review Capacity to give TPD staff a better understanding of the Business Transformation Initiatives and their link to the Therapeutic Access Strategy (TAS). The fact sheets were distributed at the Business Transformation Forum, and sent to all TPD Bureaus. An electronic version of the fact sheets was also sent to all TPD staff and internal and external stakeholders.
  
  
• To communicate the results of the May 10^th and November 19^th Extended Management Retreats (EMR), two Communiqués were released to all TPD staff and key stakeholders in June 2004 and January 2005, respectively.
  
  
• In October, an information CD was created to include all issues of the TPD News, News Specials, Communiqués, the Business Transformation Fact Sheets, and the Business Transformation Progress Report. The format makes it easier to share our communications products with staff and stakeholders.
  
  
• The Change Management Survey was developed and distributed to all TPD staff to assess how we are doing in the area of communications and implementation of project management. The survey results overall are encouraging and informative. Staff are generally satisfied with the project management approach. Additionally, the survey has shown that there are a number of areas where communication can be improved and training can be more effective.
  
  
• A stakeholder survey was distributed electronically to the four external stakeholder groups mailing list. The survey focused on TPD's interest in finding out the extent to which our communications and initiatives have been effective. The responses will help us to measure stakeholder level of satisfaction with our initiatives and communication efforts and allow for modifications where necessary.
  
  
• An Annual Business Transformation Progress Report and a performance highlights report was produced and distributed to TPD staff and internal and external stakeholders in July 2004 and January 2005, respectively. The report reflects the work and progress being done within TPD on the various TAS and Core Engagement Team (CET) initiatives and illustrates how we are managing to not only meet our goals, but in some cases surpass them.
  
  
• The CET created and distributed to TPD staff a Good Communications Handbook by compiling all the articles that had appeared in the TPD News about how to communicate effectively.

Engagement Events

• An all-staff TPD Information Forum on the business transformation initiatives took place on June 2, 2004. This was an opportunity to learn more about how TPD is progressing with its different business transformation initiatives and our strategic priorities. A series of brief presentations/ discussions on the seven key initiatives in TPD over the next 12 months, as well as a CET Progress Update were provided as follows: CET Progress Update, Product Monograph, Summary Basis of Decision, Good Guidance Practices, Good Review Practices, E-Review, International Regulatory Cooperation/Harmonization, and Managing the Plan: An Overview of Roles/Responsibilities in Managing the Submission Review Plan.
  
  
• To facilitate communication between the TAS project leads (GGP, GRP, Enhanced Review Capacity, Change Management, SBD, Product Monograph, Project & Workload Management, International Regulatory Cooperation, International Harmonization, E-Review), OBT organizes monthly meetings to discuss TAS Secretariat activities, provide project updates, and share other pertinent information.
  
  
• On April 21, 2004 a Senior Management Retreat brought together the members of TPD-Directorate Management Committee to provide information on Year 1 of TPD's Business Transformation Strategy, and to answer questions that are surfacing with respect to linkages between the initiatives and the nature of their collective impact on our organization in Fiscal Year 04/05.
  
  
• TPD held a one day Extended Management Retreat on Monday May 10^th, 2004, which was a follow-up to the April 21^st Senior Management Retreat of the Directorate Management Committee. The objectives of the retreat were to develop a collective understanding of the initiatives being managed in the Directorate over the next 12 months; to understand senior management roles and responsibilities with respect to these initiatives; and, to reaffirm our commitment to achieving our performance objectives for 04/05.
  
  
• TPD held a one day EMR on Friday November 19^th, 2004. The objectives of the retreat were to review workload management progress, examine future trends in the health industry and their impact on TPD, and to consider opportunities for innovative models for conducting regulatory reviews.
  
  
• A moral and recognition all-staff meeting was held on June 4, 2004 as an opportunity to celebrate outstanding work in TPD by individuals and teams.
  
  
• An all-staff meeting was held on February 17, 2005 at the Banting Theatre as an opportunity to celebrate outstanding work in TPD by individuals and teams. It served as both an awards ceremony and a farewell to outgoing Director General Dr. Robert Peterson.
  
  
• TPD undertook a review of its planning process, on April 30, 2004. A group of TPD staff met for a half-day workshop to discuss the intended outcome of the renewal initiative, potential benefits, issues related to the current planning process and the renewal initiative, and potential approaches to address these issues.

Training

• A half-day performance measurement workshop was organized for the benefit of the project leads of the various initiatives and held on September 28, 2004. The Office of Business Transformation worked with the Information, Analysis and Connectivity Branch to develop a customized half-day Performance Measurement Workshop linked to the Business Transformation Initiatives for the BT Project Leads and RPMs. The purpose of the workshop was to impart information on performance measurement and associated terminology, as well as the benefits of using performance measurement to manage effectively and make timely decisions. Another Performance Measurement Workshop targeted at managers who expressed an interest in receiving information on performance measurement was held on March 31, 2005.
  
  
• The three-day competency-based project management training program was developed and delivered by the highly capable and enthusiastic team - Acerra Learning Inc. In total, 24 three-day project management training sessions were delivered to TPD staff with 97 per cent of the organization having completed the program. The competencybased project management training program complemented TPD's implementation of a project management approach to help meet performance targets for reviewing drug submissions and medical device applications
  
  
• A formative evaluation of the Project Management Training program was conducted in the Summer 2004. Each training session was independently evaluated using an in-class evaluation survey where the students rated the course, the instructor, and the course content. The data analysis indicates an overall course rating of 5.53 out of a possible 6.0. The course, instructor, and the course content all received a rating between 5.4-5.7 (very good to excellent).
  
  
• An Effective Project Management Skills Training Program was designed to build upon the project management knowledge possessed by this group and give them a complete skill set aimed at helping them successfully manage their projects from start to finish. The training was delivered to SRPMs and RPMs. The training was followed by a half-day workshop for the entire RPM team and a subsequent onehour two-on-one coaching sessions.

Future Plans 2005-2006

For the 2005/2006 fiscal year, the various business transformation initiatives have planned the activities outlined below:

Project Management/Workload Management

• Ongoing staffing of vacant RPM/SRPM positions (ie. staff turnover).
  
  
• Continue to refine review plans.
  
  
• Continue to train new and existing RPMs.
  
  
• Develop process improvements.
  
  
• Develop a prioritization and action plan for required SOPs to be revised/developed by the Good Guidance Practices.
  
  
• Additional communication with TPD staff to ensure an understanding of the roles and responsibilities of RPMs and the project management initiative.

Good Guidance Practices

• Post report of internal and external needs assessment on the Web site.
  
  
• Complete discussions with TPD and BGTD management regarding the definitions, roles and responsibilities of GGP.
  
  
• Finalize the GGP manual followed by internal and external consultations.
  
  
• Continue communication and consultations.
  
  
• Expand the inventory of existing guidances to include historical documents, including Information Letters.
  
  
• Adhoc addition to the guidance development list as issues arise.
  
  
• Work will continue on several pilot guidance projects that have been informally chosen.

Good Review Practices

• Post external consultation report on Web site.
  
  
• Draft and pilot Pharmaceutical Safety and Efficacy SOP Template.
  
  
• Finalize Pharmaceutical Safety and Efficacy Review Template.
  
  
• Prepare action plan and develop draft of Pharmaceutical Safety & Efficacy Clinical Trial Application Template.
  
  
• Prepare action plan and develop draft of Reviewer Orientation Program (Phase I).
  
  
• Prepare action plan and develop draft of Executive Summary Template.

Transparency - Product Monograph

• Evaluation of the product monographs submitted will be started first quarter of 2005/2006.
  
  
• External consultation on the Issue Analysis Summary.
  
  
• Develop a preliminary resource assessment for implementation of the Public Availability of the Product Monograph.

Transparency - Summary Basis of Decision

• Continue Phase I implementation relating to the preparation and publication (to TPD/BGTD Web sites) of SBD's for approved submissions for New Active Substances (New Drug Submissions) and a subset of Class IV medical device applications.
  
  
• Develop, pilot and implement a macro to be used in conjunction with the review templates.
  
  
• Continue policy analysis to support progression of the initiative into Phases II and III including:
  
  
  • evaluate infrastructure, anticipated submissions, resource requirements, and feedback received on Phase I of the initiative;
  • explore and initiate as appropriate evaluation methods to solicit critical feedback from affected stakeholders (on Phase I); and
  • analyze required consultations to support expansion of the SBD initiative into Phase II.
    
    
• SBD Phase II (All Submissions) - Not to be undertaken until 2006.

E- Review

• Production roll out of SAP and CT-ADR systems.
  
  
• Continue to support receiving and handling submissions in eCTD format (paper co-submission)
  
  
• Continue to address legal, security, and privacy issues.
  
  
• Complete the groundwork to address hybrid submissions (Modules 1 and 2 paper and electronic,Modules 3 to 5 electronic only) and commence a proof of concept implementation.
  
  
• Proof of concept and a pilot implementation of an electronic document management system.
  
  
• Proof of concept and a pilot implementation of a tracking and workflow system.

Enhanced Review Capacity

Therapeutic Class Specific Standing Committees as follows:

• A SAP on Reprocessing of Medical Devices meeting in May 2005.
  
  
• A SAP on Non Steroidal Anti-Inflammatory Drugs (NSAIDS) teleconference in May 2005.
  
  
• Two new SAC's will be formed - Ophthalmology and Respiratory Diseases.
  
  
• A SAP on Isotretinoin in April 2005.
  
  
• A SAC-MDUCS in June 2005.
  
  
• A national stakeholder consultation on reprocessing single use devices in May 2005.
  
  
• Meetings of other SAPs as the need arise.

Activities related to the procurement of external scientific experts as follows:

• Develop contracting strategy for science experts and implement.
  
  
• Finalize the contract process map and SOP.
  
  
• Develop and implement the Database (inventory of experts).
  
  
• Populate the Inventory of Experts.
  
  
• Develop an outreach strategy and communications plan to grow the inventory based on experiences from the BCANS pilot.
  
  
• Deliver a SOW Training course.
  
  
• Develop content for the Introductory Training modules for potential scientific expert inventory candidates as well as investigating delivery formats and length of training.
  
  
• Deliver training on Contract Processing with Review Bureaus.

International Regulatory Cooperation

• Develop the TPD International Strategy.
  
  
• Update the inventories of international initiatives on an ongoing basis as TPD becomes aware of new IRC activities or significant changes to existing ones.
  
  
• Continue to establish procedures under the FDA MOU implementation plan for the exchange, documentation, protection, use, and monitoring of information.
  
  
• Establish steering and operational committees to oversee and evaluate the exchange of information and staff, in collaboration with ORIA.
  
  
• Continue to deliver training in TPD on good inter-agency practices regarding communication and confidentiality issues stemming from the signing of MOUs.
  
  
• Retrospective review of three drugs reviewed by the FDA and TPD with a view to better understanding similarities and differences in risk assessment and decision-making.
  
  
• Continue discussions around the overall Framework for Cooperation including the identification of further collaborative efforts (Office of New Drug Chemistry (ONDC)/BPS North American CMC Discussion Group).
  
  
• Participate in a potential training session offered by ONDC the Process Analytical Technology (PAT) guidance for reviewers.
  
  
• Pursue a pilot project with CDER on parallel review of new drugs as a potential step towards a more formalized work arrangement.
  
  
• Pursue an expanded and more formalized cooperation with CDRH on medical devices, with a focus on quality system audit programs, the exchange and use of regulatory information, developing common approaches to Global Harmonization TASk Force (GHTF)-related issues, training, and the development of a framework and mechanisms for cooperation.
  
  
• Attend a future EMEA Working Party meeting to review comments and finalize the joint HC-EU guidance on the Pharmaceutical Quality of Inhalation and Nasal Products.
  
  
• Submit a proposal on informal cooperation between HPFB and EMEA - following current focus on enlargement and implementation of new pharmaceutical legislation and regulatory duties, explore the possibility of an MOU with EMEA.
  
  
• Continue the Visiting Experts Program, including the possible study of standards and procedures associated with the new Clinical Trials Directive.
  
  
• Commence and complete the pilot phase of comparison of review processes (EDQM) in April 2005. Once evaluation and pilot program is complete, a decision on official recognition of the EDQM's Certificate of Suitability will be made. HPFB - SFDA Senior Officials Meeting (SOM) with proposed meeting goals to include the official endorsement of SOM terms of reference, work plans and the protocol for staff exchange, extension of the HPFB-SFDA Plan of Action, and the development of a communication strategy. Work plans involving TPD will focus on pharmaceutics (quality and bioequivalence), medical devices, and clinical trials.
  
  
• Arrange for two SFDA staff to study the drug evaluation process for pharmaceuticals as part of a World Health Organization funded visiting studies program. Sign an MOU and the acceptance of applications for certification with the TGA.
  
  
• Work will continue with the International Agreements Committee to develop the MOU and a draft implementation plan that reflects agreed upon priorities.
  
  
• Revise and circulate the draft International Review Guidance for broader internal and external comments followed by a 12 month pilot.
  
  
• Compare the regulatory requirements, procedures, and practices of bench-marked agencies as part of a confidence building exercise.

International Harmonization

• Continue work with the Women's Bureau on the development of additional guidance and definitions on gender/sex considerations in clinical trials for posting together with the ICH document.
  
  
• Continue Steering Committee discussions around the future of ICH based on papers prepared by the parties, including Health Canada.
  
  
• Develop two to three concept papers for new priority topics in the area of pharmacovigilance (ICH).
  
  
• Draft regulations and move them through the regulatory process, including Canada Gazette I and II before the end of fiscal (HPFBI).
  
  
• Continue work on a number of ICH guidances and topics.
  
  
• Examine the outcomes of all the activities of the National Placebo Initiative and examine options for moving forward with an addendum to the ICH guideline E10 (Choice of Control Group and Related issues in Clinical Trials).
  
  
• 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.
  
  
• Continue work with other international groups of experts involved in setting public standards, methodologies, and monographs.
  
  
• Continue to participate in three expert US Pharmacopoeia committees involved in standard setting and drug information.
  
  
• Develop proposals for TPD participation in selected European Pharmacopoeia expert groups.

Change Management

The following Communications Products will continue to be produced:

• Quarterly TPD News.
  
  
• EMR communiqués.
  
  
• TPD Business Transformation Annual and Mid-term Performance Highlights Progress Reports.
  
  
• A Change Management Survey will be conducted in the Fall 2005.

The following engagement events will be planned:

• Two Extended Management Retreats.
  
  
• An all-staff meeting.
  
  
• Regular Advisory Committee Management Meetings (ACM).
  
  
• Bilateral meetings.

The following training is planned:

• Publish a Request for Proposal for the Management Training Program and investigate the various options and service providers to determine the management training program that will best fit the needs.
  
  
• Develop a Performance Discussion Process Training Program for Managers.
  
  
• In support of the Enhanced Review Capacity Unit there is a plan to create an E-learning training program for the external scientific expertise that will be contracted with. The training program will help the external scientific experts do the assigned work more effectively and efficiently.