1. GOVERNANCE MODELS OF OTHER NETWORKS: APEC AND IMDRF 7 TH PAN AMERICAN CONFERENCE ON DRUG REGULATORY HARMONIZATION 5-7 SEPTEMBER, 2013 OTTAWA

2. Elements of an effective approach Be clear on what you want to achieve, with who and why Establish the business case Develop a strategy or roadmap on how to achieve desired outcomes Be practical: step-wise approach, taking account of what already exists

3. An Example: APEC RHSC Formed in June 2009, APEC Regulatory Harmonization Steering Committee (RHSC) serves unique role in promoting regulatory convergence Regional initiative that marshalls resources of regulators, industry coalitions and academia towards common goals and objectives, serving as catalyst for sustained international action Work guided by Strategic Framework and roadmaps Designed to play complementary role to other regional and international regulatory initiatives 3

4. APEC Asia-Pacific Economic Cooperation (APEC) created in 1989 21 member economies account for 40 % of world population, 54% of GDP and 44% of world trade Goals: Promote trade, sustainable economic growth and prosperity of member economies through policy alignment and economic and technical cooperation APEC agenda and annual work plan developed around SOMs culminating in Leaders declaration APEC Chair rotates annually (US 2011, Russia 2012, Indonesia 2013, China 2014) 4

5. Source: APEC

6. RHSC Mandate To promote a more strategic, effective and sustainable approach to harmonization by: –Proactively identifying and prioritizing projects seen to be of greatest value –Strengthening linkages with harmonization initiatives, training organizations and other key players to promote complementary actions and most effective use of resources –Ensuring sustained efforts –Products of interest: medical products, including medical devices, pharmaceuticals and advanced therapies

7. Members Regulators from 12 APEC Economies: –Canada, China, Chinese Taipei, Indonesia, Japan, Korea, Malaysia, Mexico, Peru, Singapore, Thailand, US Industry coalitions: –Research based pharmaceutical sector –Medical Devices sector –Generic pharmaceutical sector –Biotechnological products sector Academia: Director of APEC Harmonization Center Secretariat located in Seoul, Korea Chair/Vice-Chair, with 2 meetings per year

8. APEC Harmonization Center APEC-wide resource to enhance and sustain regulatory convergence and capacity building efforts Formed in June 2009 has played instrumental role in supporting RHSC workshops and projects To date organized and sponsored over dozen international workshops and supported travel of regulators from travel eligible economies

9. Linkages Establishment of official liaisons with international harmonization initiatives and organizations, including AHWP, ICH, IMDRF, PANDRH, WHO, European Medicines Agency Reflects position that APEC should act as a catalyst for international action on issues that demand a global approach

10. Framework outlines strategic multi-year approach for achieving greater regulatory convergence by 2020 Describes guiding principles and general multi-step approach Voluntary action: each economy proceeds at own pace Includes definition of regulatory convergence and suggested indicators of success Endorsed by APEC Ministers in November 2011 Strategic Framework 10

12. Priority Work Areas (PWAs) PWAs and Champion Economies: – MRCTs (Japan) – Supply chain integrity (US) – Good Review Practices and Combination Products (Chinese Taipei) – Biotech Products and Pharmacovigilance (Korea) – GCP Inspection (Thailand) – Cellular Therapies (Singapore)

13. Examples of Concrete Action Pilot program for establishing Centre of Excellence for Multi-regional Clinical Trials to promote global drug development Gap Analysis, workshops and development of toolkits under Supply Chain Integrity roadmap (with aid of $0.5 M USD in APEC funds) Develop paper and elements of training curriculum on Good Review Practices: lays foundation for WHO guideline

14. Building a Better Harmonization Model ICH, IMDRF Development Organizations (Standards, Guidance, Tools) Key Enabler: RHSC + APEC Harmonization Center Key role played by WHO

15. International Medical Device Regulators Forum (IMDRF)

16. Global Harmonization Task Force (GHTF): created in 1992 as voluntary harmonization initiative comprised of regulators and industry from Europe, US, Japan, Canada and Australia Purpose: encourage convergence in regulatory requirements, practices and systems to promote: – safety, effectiveness/performance and quality of medical devices – technological innovation,and – international trade Mechanism: harmonized guidance documents on basic regulatory practices developed by five Study Groups GHTF 16

17. Over 50 guidances and documents that define the most important elements of a harmonized regulatory system GHTF Regulatory Model which integrates all guidance documents over medical device lifecycle Reference and forum for exchange with countries with developing medical device regulatory systems, notably those part of Asian Harmonization Working Party (AHWP) Accomplishments 17

18. With existing GHTF work coming to an end, regulatory members felt a new operating model was necessary to achieve original GHTF objectives and meet the increasing challenges of globalization and emerging technologies Recognition that many of the products of GHTF had not been implemented by founding members Time for Change 18

19. Increasing need for environment conducive to promoting inter- agency cooperation, moving cooperation beyond development of work products Recognition that regulators have ultimate responsible for protection of public heath, and in so doing interacting with many stakeholders Changing global face of product development, manufacture and marketing Lessons learned: including importance of selecting limited number of well-defined work items of high value and limited duration which may then be implemented by regulators Considerations 19

20. Launched in February 2021, chair and secretariat rotate on annual basis, beginning with Australia (2012), EU (2013), US (2014) Broader membership than GHTF, now including Brazil and China AHWP and APEC endorsed as Affiliate Organizations: signals importance of close cooperation in achieving common goals Two 3 day meetings per year; includes public session Proposals and comments may also be submitted at any time, including through website Important Facts 20

21. While management committee (MC) composed of regulators, the Forum - and notably working groups - may and do include industry and other stakeholders Two types of IMDRF work products: governance and technical Decisions by consensus and not voting In exceptional cases, an MC member organization my opt-out of a technical activity Important Facts 21

22. Organizational Structure

23. New Work Items (NWIs) endorsed by MC define technical work of IMDRF and remit of Working Groups (WGs) WGs will be disbanded once assigned work completed WGs will generally include stakeholders with significant involvement and expertise in topic WGs responsible for matters relating to regulatory practices or exchange of confidential information will be comprised of regulators Important Facts 23

24. IMDRF efforts build upon solid foundation provided by GHTF work products MC committed to rapid progress and concrete deliverables Transparency and engagement key to building trust Goal of regulators and industry aligned: true regulatory convergence and harmonization ->IMDRF is the vehicle Important Messages 24

25. Muchos Gracias Obrigado Merci Thank you