1. “Good Regulatory Practice” initiatives with APEC LSIF Li-Ling Liu Director, Division of Medical Devices and Cosmetics, Food and Drug Administration Chinese Taipei 13th AHWP TC MEETING 2011.07.07

2. 2 Outline Background APEC-funded Best Regulatory Practice proposal 2011 Good Review Practice Workshop in October for Pharmaceuticals and Medical Devices

3. Food and Drug Analysis Food Safety FDA supersedes the following 4 bureaus of Department of Health Controlled Drugs Pharmaceutical Affairs FDA was inaugurated on Jan. 1, 2010

4. 4 Established on January 1, 2010 79 full-time staff in Div. of Medical Devices & Cosmetics

5. Objectives of Medical Device Administration Medical Device Administration To Protect Public Health To Strengthen Regulatory System To Promote Development of Biomedical Industry To Promote International Collaboration

6. 6 The AHWP and APEC member economies are largely overlapping Abu Dhabi India Jordan Kingdom of Saudi Arabia Pakistan South Africa Yemen Australia Canada Japan Mexico New Zealand Papua New Guinea Peru Russia United States Chile China Chinese Taipei Hong Kong Korea 22 Member economies21 Member economies Cambodia Lao PDR Myanmar Brunei Indonesia Malaysia Philippines Singapore Thailand Vietnam ASEAN

7. 7 LSIF VI Meeting August 2008, Lima Peru: a turning point Outcomes: Series of recommendations, including two of strategic importance: 1. Support for the establishment of the APEC Harmonization Center (AHC) 2. Creation of a Regulatory Harmonization Steering Committee (RHSC)

8. 8 The Harmonization Efforts of LSIF conform with APEC 2011 Themes Three priority areas have been outlined as APEC 2011 themes: 1. Strengthening regional economic integration (REI) and expanding trade 2. Promoting green growth 3. Expanding regulatory cooperation and advancing regulatory convergence 2010 APEC Leaders’ Declaration: Increasing regulatory cooperation and improving the use of good regulatory practices among APEC economies are the key steps toward realization of the economically-integrated community.

9. 9 Promotion of Good Regulatory Practice in different international organizations OrganizationASEANAPEC CommitteeACCSQ (ASEAN Consultative Committee for Standards and Quality) SCSC (Standards and Conformance Sub-Committee) LSIF RHSC SectorsAutomotive product; Wood-based product; Rubber-based product; Cosmetic product; Medical product etc. Electrical and electronic equipment etc. Medical products Common Objectives Intend to assist member economies in the adoption of efficient regulatory arrangements, which should lead to reductions in regulatory barriers to trade Promote use of existing international standards/guidances Promote mutual recognition of the results of conformity assessment activities Establish appropriate post-market surveillance regimes where applicable

10. 10 RHSC Members Regulators from Canada, China, Chinese Taipei, Japan, Republic of Korea, Peru, Thailand and USA with official observers from Mexico and Singapore Industry representatives from innovative drug and medical device sectors

11. 11 RHSC Mandate and Goals RHSC meant to promote a more strategic, effective and sustainable approach to harmonization within the APEC region by: – – Proactively identifying and prioritizing projects seen to be of greatest value – – Providing direction to the AHC on projects and activities that best meets these needs – – Enhancing the effectiveness of interactions with international and regional harmonization initiatives – – Promoting the establishment of APEC networks of technical experts and repository of reference materials – – Supporting mechanisms for the sharing of regulatory information and best practices Products within remit of SC: medical life science products (notably drugs and devices)

12. 12 Discussion in the LSIF RHSC meeting, March 2-4, 2011, Washington DC A Strategic Framework for Regulatory Convergence for Medical Products by 2020 Proposals for Projects Projects to support overall strategy and components of Roadmaps Multi- Regional Clinical Trials Good Review Practices Product Quality Pharmaco- vigilance Post-market Surveillance Pharmaceuticals Medical Devices Regulatory Convergence For Medical Products 2020 Clinical Evidence Good Review Practices Quality Management System

13. 13 Outline Background APEC-funded Best Regulatory Practice proposal 2011 Good Review Practice Workshop in October for Pharmaceuticals and Medical Devices

14. “Best Regulatory Practice” project proposed by Chinese Taipei 14 “Best Regulatory Practice of Medical Products for Trade Facilitation” - a strategic approach for Good Review Practice Co-sponsoring APEC Economies: Canada, China, Indonesia, Korea, Malaysia, Mexico, Peru, Philippine, Thailand and United States Approved and funded by APEC in December, 2010 (CTI-LSIF 35/2010T)

15. Key Objectives -1/2 15 promoting awareness and the adoption of Good Regulatory Practice among regulatory authorities and stakeholders within the APEC region. …reducing regulatory burden and achieving timely market access of medical products to provide a platform for regulatory dialogue and experience sharing thereby facilitating cooperation and regulatory convergence. This effort will include the exchange and use of regulatory information among regulatory authorities within the APEC economies to further promote regulatory efficiencies and best practices.

16. 16 Key Objectives -2/2 Participating economies will be able to: recognize the importance of good review practices to a well-functioning regulatory system and to establish mutual confidence in the assessment reports of regulatory authorities within the APEC region have an appreciation of how the reports of other trusted agencies may be systematically used to improve the overall efficiency and effectiveness of their product assessment processes lead to changes in review behaviour and policy amendment for developing their regulatory practice

17. 17 Three components of the project -1/2 A survey to examine the disparities of Good Review Practice and approaches to scientific assessments among APEC economies to collect data on current practice by participating agencies. A pilot study on use of available regulatory review reports from other participating agencies by voluntary basis. A series of 3 to 5-day Good Review Practice Workshops covering both pharmaceuticals and medical devices will be held in Chinese Taipei in 2011 and 2012.

18. 18 2011(1H)(2H)2012(1H)(2H) Survey-diagnostic, gap analysisannual survey design Propose pilot for using and exchanging review reports Pilot project regulatory dialogue 2 basic alignment workshops (10/11-10/15) 2 adv. gap- filling workshops Working meetings w/ 4 RHSC’s (for sustainable development: points to consider, curriculum, white papers etc.) Three components of the project -2/2

19. 19 Outline Background APEC-funded Best Regulatory Practice proposal 2011 Good Review Practice Workshop in October for Pharmaceuticals and Medical Devices

20. 20 GxP and QMS Common Objectives: Consistent, high quality products Industry GMP GDP GCP GPhVP …etc QMS Regulators Good Regulatory Practices Good Review Practices

21. Medical Devices Life Cycle and Regulation Request for Designation Consultation Pre-IDE GLP/GTP GCP GMP Pre-PMA Regulation / ActPost-marketing Surveillance Advisory Committee Obsolescence ConceptPrototypePreclinical Clinical ManufacturingRegistrationMarketing

22. Good Review Practice Ensure the timeliness, predictability, consistency, and high quality of reviews and review reports Review standard and related initiatives Efficient management of the review process Active applicant involvement

23. Filing Determination and Review Planning Phase Review Phase Post-Action Phase Advisory Committee Meeting Phase Action Phase The Key Phases of Review Process

24. Specific Characteristics for Medical Devices Medical devices are interdisciplinary innovation. The life cycle of medical devices is short. The pace of innovation is rapid.

25. The Hallmark of GRP Good Review Practice QualityConsistencyTransparencyClarityEfficiency

26. 26 Preludes Medical device promotional Good Review Practice workshop hosted by Chinese Taipei in June 2010 Recommendations from the workshop help with design of two year project funded by APEC

27. Recommendations- 1/2 1. The general principles for Good Review Practice include quality, efficiency, clarity, transparency, consistency and predictability. 2. Fundamental elements of a well-designed regulatory review system, including basic functions, systems, procedures and templates along with in-depth case studies targeted on the regional needs are suggested to be covered. 3. In addition to the continuous on-job professional training of reviewers, the cultivation of the mentality and communication skills were also recommended.

28. Recommendations- 2/2 4. Industry play important roles on medical products review process, such as submission of a complete marketing application, active applicant involvement and arrangement of well-trained personnel on regulatory affairs for product registration. 5. Special topics for devices include: (a) Regulatory issues such as sharing and exchange of the review templates; quality assurance and accreditation of third parties (b) Technical issues such as the review of devices utilizing ICT technology (c) Considering adoption of GHTF model

29. 29 “Save the date”: October 11-15, 2011 APEC Good Review Practice Workshop on Medical Products 23 Please check “APEC Events Calendar” for more details: http://www.apec.org/en/Events-Calendar.aspx

30. Overview of the Preliminary Program 30 Oct 11 (Tue) ampm Reg./pre-meeting Evening Reception Oct 12 (Wed) Joint- Fundamentals Breakouts Oct 13 (Thur) Breakouts Joint-conclusions Oct 14 (Fri) Dialogues with Industry-Network of Regulatory Science for Pharmaceuticals and Devices Oct 15 (Sat) Recommendations/ Final remarks

31. 31 Session A Keynote Speech Moderator: Dr. Jaw-Jou Kang Director-General Food and Drug Administration, Department of Health, Chinese Taipei 09:30–10:00 Role of APEC LSIF in Promoting Regulatory Harmonization Mr. Mike Ward APEC LSIF RHSC Chair Manager, International Program Division, Therapeutic Products Directorate, Health Canada 10:00-10:30 APEC LSIF RHSC Best Regulatory Practice Proposal from Chinese Taipei Ms. Li-Ling Liu Director, Division of Medical Devices and Cosmetics, Food and Drug Administration, Department of Health, Chinese Taipei 10:30–11:00Coffee Break Session B Observation of Good Review Practice Implementation Moderator: Representative from APEC LSIF RHSC 11:00–11:30 Scorecard and Measurement of GRP for Regulatory Agencies – GRP Proposal Survey Report Recommend by CDE, Chinese Taipei (TBD) 11:30–12:00 GRP Implementation on Assessing Combination Products TBD 2011 APEC Good Review Practice Workshop on Medical Products -1/6 10/12 am: Fundamentals for all regulators

32. 32 10/12 pm: Parallel sessions – – Capacity Building – – Tools for Good Review Practice 26 2011 APEC Good Review Practice Workshop on Medical Products -2/6

33. \ 33 10/13 am: Parallel sessions – – Decision Making and Communication 27 2011 APEC Good Review Practice Workshop on Medical Products -3/6

34. 34 28 2011 APEC Good Review Practice Workshop on Medical Products -4/6 10/13 pm: Parallel sessions - Quality Assurance - Case Studies Joint session - Summary Sharing

35. 10/14: Dialogue-APEC Network of Regulatory Science for Pharmaceuticals and Medical Devices attended by regulators and industry 35 2011 APEC Good Review Practice Workshop on Medical Products -5/6 10/14: Dialogue-APEC Network of Regulatory Science for Pharmaceuticals and Medical Devices attended by regulators and industry

36. 36 10/15: Joint Recommendations/ Final Remarks 2011 APEC Good Review Practice Workshop on Medical Products -6/6 10/14: Dialogue-APEC Network of Regulatory Science for Pharmaceuticals and Medical Devices attended by regulators and industry

37. 37 More information about the “2011 APEC Good Review Practice Workshop on Medical Products” Participants from all APEC economies are welcomed and invited to attend this workshop, especially targeted on chief officials or senior reviewers who also hold decisive roles from regulatory authorities. Non-authorities representatives are welcomed to attend this workshop on October 14 which is the only day open to the public. Travel fund is available for up to two participants from each APEC travel-eligible economy: Chile, China, Indonesia, Malaysia, Mexico, Papua New Guinea, Peru, Russia, Thailand, the Philippines and Viet Nam. Estimated participants from 14 economies

38. 38 Conclusions All the economies are encouraged to participate in this project and work towards expanding regulatory cooperation and advancing regulatory convergence all together. Through implementing Good Review Practice, not only the quality, efficiency, clarity, transparency, consistency and predictability can be improved, but also establish mutual confidence in the assessment reports of regulatory authorities. APEC economies will focus their coordinated efforts on promoting harmonization by collaborating with international organizations, such as GHTF, AHWP and ASEAN.

39. 報告完畢 敬請指教 39 39 3939 Thank You for Your Attention Thank You for Your Attention http://www.fda.gov.tw