2010/SOM3/LSIF/032 LSIF Initiatives Medical Devices Global Regulatory Harmonization and Anti-Counterfeit Medicines Global Cooperation

Transcription

1 2010/SOM3/LSIF/032 LSIF Initiatives Medical Devices Global Regulatory Harmonization and Anti-Counterfeit Medicines Global Cooperation Submitted by: United States Life Sciences Innovation Forum Sendai, Japan September 2010

2 APEC LSIF APEC LSIF INITATIVES Medical Devices Global Regulatory Harmonization and Anti-counterfeit Medicines Global Cooperation APEC LSIF Annual Meeting September 18-19, Sendai, Japan Presented by: Jeffrey L. Gren Director, Office of Health and Consumer Goods, U.S. Department of Commerce Presentation Outline Introductory Comments Global Medical Devices Regulatory Harmonization Training Vision; Goals and Objectives; Past Results and Future Plans APEC Anti-counterfeit Medicines Activities Results and Future Plans APEC LSIF Anti-counterfeit Medicines Action Plan Summary and Conclusions 2 1

3 Global Medical Devices Regulatory Harmonization Vision To reduce redundancies in medical device regulatory review procedures and to promote product safety To work towards common APEC-wide medical devices regulatory procedures and requirements in the future (such as 2020) These GHTF harmonization goals will be confirmed by the Regulatory Harmonization Steering Committee (RHSC) for endorsement by the LSIF and senior officials/ministers i i i following the Sendai LSIF Annual Planning Group meeting Global harmonization is good for regulators, patients, and industry 3 Global Medical Devices Regulatory Harmonization Training Goals and Objectives To educate APEC and medical devices regulators from nonfounding GHTF countries in the process of developing or updating their regulatory regimes based upon GHTF guidance documents To provide an understanding of GHTF Study Group guidance documents 4 2

4 GHTF Training Benefits Regulators benefit from a harmonized global medical device regulatory system because it eliminates redundant reviews, creates an opportunity to share information on product safety and results in a more efficient regulatory regime Industry benefits from a harmonized medical device regulatory system because it eliminates redundant requirements that do not contribute to safety 5 Past GHTF Regulatory Harmonization Training Events March 1999 APEC Funded Seminar Singapore May 2001 APEC Funded Seminar Singapore June 2005 APEC Funded Seminar Bangkok, Thailand May 2006 APEC Funded Seminar Santiago, Chile July 2007 ASEAN Seminar, Hanoi, Vietnam October 2007 GHTF Organized Latin American Seminar, Washington, D.C. February 2008 APEC Funded Seminar KL, Malaysia March 2009 ASEAN Seminar Penang, Malaysia May 2009 APEC Funded Seminar Toronto, Canada September 2009 APEC Funded Asia Delegation Visit to Australia September 2009 USDOC Funded Seminar Brasilia, Brazil August 2010 APEC Funded Delegation Visit to Canada and the United States 6 3

5 Most Recent Event August 2010 APEC Medical Devices Delegation Visit to Canada and U.S. (cont d) August Regulatory Training Health Canada August Industry hosted firm visits in Boston Area to BD, DePuy, Boston Scientific and Phillips organized by AdvaMed August Regulatory Training U.S. FDA Delegation included 29 regulators from China, Philippines, Thailand, Malaysia, Indonesia, Russia, Papua New Guinea, Chile, Peru, Mexico, Brazil, Costa Rica, South Korea, Hong Kong and Singapore 7 Most Recent Event August 2010 APEC Medical Devices Delegation Visit to Canada and U.S. (cont d) Evaluations were excellent sample comments Training very beneficial for [my economy] especially because we are about to harmonize requirements among ASEAN countries Thank you very much. Great opportunity, and very useful. Learned much about GHTF model for guidance documents and how Heath Canada and USFDA apply GHTF principles shed light on how [my economy] could adopt GHTF model into our regulations 8 4

6 Delegation Pictures 9 Delegation Pictures 10 5

7 APEC/GHTF Medical Devices Regulatory Training Results The following economies have revised or are in the process of revising their medical device regulatory regimes based on GHTF principles: Malaysia Singapore Hong Kong ASEAN countries as part of ASEAN ACCSQ Medical Device Products Working Group (i.e. Thailand, Indonesia and Philippines) Saudi Arabia 11 APEC/GHTF Medical Devices Regulatory Training Results Participants in past GHTF training have reported that: Seminars useful to develop strategies to advance the use of GHTF guidance documents Participating economies have moved toward the Technical STED Model (Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices) APEC economies are likely to continue adopting GHTF guidance documents in the next three to ten years Participating economies have requested support in implementation of new or revised regulatory regimes 12 6

8 APEC/GHTF Medical Devices Training: Examples of Topics Covered GHTF Study Group 1 Definition of a Medical Device Essential Principles of Safety and Performance of Medical Devices Summary Technical Documentation Conformity Assessment In Vitro Diagnostics and Global Harmonization Principles of Medical Device Classification Role of Standards in Assessment of Medical Devices GHTF Study Group 2 Adverse Event Reporting Reporting Timeframes Vigilance Systems: Some Practical Issues 13 APEC GHTF Medical Devices Training: Topics Presentations (continued) GHTF Study Group 3 ISO 13485: Overview Quality Management Systems: History and Evolution Implementation of Risk Management Principles Introduction to Design Verification and Validation FDA Export Certificates Process Validation Guidance Quality Management Systems: History and Evolution 14 7

9 APEC GHTF Medical Devices Training: Topics Covered Presentations (continued) GHTF Study Group 4 Auditing and Overview of GHTF Plan-Do-Check-Act Case Study GHTF Study Group 5 Clinical Evidence Special Presentations New Medical Technologies: Challenges for Regulators Essential Principles of Safety and Performance of Medical Devices Medical Device Regulatory Global Crystal Ball Forecast 15 Future APEC/GHTF Training Plans (cont d) GHTF Ad Hoc Training Committee, Exploring Possible Future Partners for GHTF Training Programs Possible Follow-up to March 2009 ASEAN Workshop Possible Follow-up to September 2009 Brazil Workshop Future APEC Regulatory Harmonization Projects under Guidance of the APEC LSIF Regulatory Harmonization Steering Committee (Chinese Taipei Proposal) 16 8

10 Future APEC/GHTF Training Plans (cont d) Chinese Taipei has submitted a Concept Note focused on continuing past APEC LSIF medical devices regulatory harmonization activities iti This Concept Note proposes a series of Good Regulatory Practice workshops (medical devices and pharmaceuticals) to be held in Chinese Taipei during 2011 and 2012 The workshops would address the fundamental elements of a well designed regulatory review system, along with indepth case studies The medical devices portion of proposed workshops would coordinate with GHTF 17 Introduction The Global Counterfeit Medicines Problem Factors leading to this increase in counterfeit medicines include: Increase in criminal activity and level of sophistication High profit level (even higher than for narcotics) Internet provides a marketing vehicle for counterfeiters to distribute counterfeit medicines Lack of penalties, enforcement, and coordination in prosecution in many overseas markets have created conditions for counterfeiting to grow 16 9

11 Introduction The Global Counterfeit Medicines Problem (cont d) Globalization of the pharmaceutical industry has contributed to the ready supply of APIs to counterfeiters, as manufacturing of APIs and finished dosage form medicines shifts from developed to lesser developed countries Counterfeiting impacts all aspects of the pharmaceutical industry patented drugs, generic drugs, and OTC medications Globalization has also contributed to the growth of substandard medicines 17 Introduction The Global Counterfeit Medicines Problem (cont d) Lack of vigilant il oversight can lead to supply chain vulnerability Supply chain vulnerability, in turn can lead to entry of counterfeit drugs into legitimate distribution channels Movement of API manufacturing to less developed countries has contributed to providing a supply of APIs for counterfeiters 18 10

12 APEC-Funded Anti-counterfeit Medicines - Past Activities Under the APEC Life Science Innovation Forum there is an anti-counterfeit medicines initiative The spread of counterfeit medicines is a significant problem facing APEC economies, and through joint cooperation by APEC economies we hope we can make an impact on this global problem 19 APEC Funded Anti-counterfeit Medicines Past Activities (cont d) During 2008 and 2009 APEC LSIF organized three Asia anti-counterfeit medical product seminars January 2008 and March 2008 in Singapore and a February 2009 seminar in Mexico City The three seminars had a total of over 300 participants Attendance during three seminars included regulators, customs, law enforcement and judicial officials, as well as industry representatives Findings of the APEC Anti-counterfeit medical product seminars to APEC Ministers and an APEC Anti-counterfeit Medicines Action Plan was developed We are very pleased that the APEC Anti-counterfeit Medicines Action Plan has been recently endorsed by the APEC LSIF Planning Group 20 11

13 Proposed APEC LSIF Anti-counterfeit Action Plan Strong cooperation among APEC economies is critical Cooperation within each APEC economy between regulators, customs, law enforcement, judicial and industry is also critical APEC economies should work together to collect data on counterfeit medicines APEC economies should coordinate on legislation and penalties for prosecuting drug counterfeiters 21 Proposed APEC LSIF Anti-counterfeit Action Plan (cont d) Many counterfeit medicines enter APEC economies through Internet sales. Better Internet prevention and education strategies are needed Detection technologies to identify unsafe drugs are extremely important Cooperation on the global shipment of ingredients used in the production of counterfeit medicines i is also needed d APEC cooperation on counterfeit medicines public awareness is important for patients, health professions, regulators, custom officials and law enforcement officials 22 12

14 Proposed APEC LSIF Anti-counterfeit Possible Future Activities The U.S. has submitted self funded d a new proposal to began implementation of the APEC Anti-counterfeit Medicines Action Plan A workshop on detection technologies for the safety and efficiency of medicines and APEC cooperation to stop the global shipment of counterfeit medicines and ingredient used by counterfeiters to product counterfeit medicines An exhibition of counterfeit medicines detection technologies 23 Proposed APEC LSIF Anti-counterfeit Possible Future Activities (cont d) The APEC Anti-corruption and Transparency Task Force (ACT) has organized a (September 17) Workshop in Sendai titled Fighting Corruption and Strengthening Market Integrity Joint ACT and LSIF Cooperation on Anti-counterfeit Medicine Activities were discussed during this workshop The APEC Anti-corruption and Transparency Task Force is considering a joint workshop an anti-counterfeit medicines with LSIF during 2011, the U.S. APEC Host Year In cooperation with other APEC economies, the U.S. plans to develop an additional APEC project anti-counterfeit medicines projects to take place during 2012 consistent with the LSIF Action Plan 24 13

15 Summary and Conclusion During my presentation I covered the following: APEC/GHTF Medical Devices Training, Vision, Goals and Objectives Past APEC/GHTF Medical Devices Regulatory Training Results and Future Plan APEC Anti-counterfeit Medical Products Results and Future Plans APEC Anti-counterfeit Medicines Action Plan 25 Jeffrey L. Gren Director Office of Health And Consumer Goods International Trade Administration U.S. Department of Commerce tel: 202/ fax: 202/ jeffrey.gren@trade.doc.gov 14