Global Harmonization Task Force Past, Present and Future

Transcription

1 Global Harmonization Task Force Past, Present and Future IOM Public Workshop June 15, 2010 Janet Trunzo Executive Vice President Technology and Regulatory Affairs

2 Outline Need for Harmonization Background Purpose and Governance Accomplishments Challenges Adoption of GHTF model The Future 2

3 Call for Harmonization The call for harmonization of regulatory approaches is coming from many sectors: Governments Industry Public 3

4 Why Harmonize Provide consistent application of regulatory principles and approaches Improve regulatory system effectiveness and efficiency Reduce duplication Rationalize time and costs Allow new products/technologies to enter the market place Create transparent regulatory processes 4

5 Regulatory Harmonization Harmonization is consistent with the policies of many regulatory authorities Regulatory programs are expected to: Use available international standards/guidelines as basis for technical regulations Proactively influence their development, as appropriate Consult with stakeholders/public 5

6 GHTF Background Voluntary group established in 1992 Founding Members: US, EU, Canada Australia, Japan Partnership between regulators and the regulated industry Liaisons with AHWP, ISO, IEC, WHO, PAHO 6

7 GHTF Purpose Encourage regulatory convergence in global regulatory practices Promote technological innovation Facilitate international trade Serve as information exchange forum 7

8 GHTF Governance Steering Committee Leadership rotates every 3 years by geographical region Study Groups (5) Ad Hoc Groups (7) 8

9 Organizational Structure Asian Harmonization Working Party Study Group 1 Regulatory systems Premarket assessment Steering Committee Latin American Harmonization Working Party ISO, IEC WHO GMDN Agency Study Group 2 Vigilance reporting Market surveillance PAHO Study Group 3 Quality system requirements Study Group 5 Clinical evidence ISO TC/210 9

10 Study Groups SG1 SG2 SG3 SG4 SG5 Premarket IVD Subgroup Postmarket Quality Systems Auditing Clinical Evidence 10

11 GHTF Areas of Activity Classification system and vocabulary Technical requirements Format and content of marketing applications Assessment and review practices Post-market activities Quality Management Systems requirements and audits 11

12 Ad Hoc Groups Medical Device Software Combination Products Training Global regulatory model Global medical device nomenclature Unique device identifiers GHTF administrative processes 12

13 Accomplishments Development of harmonized regulatory model Risk-based classification Harmonized definitions and vocabulary Global medical device nomenclature STED format for marketing applications Assessment and review practices Quality management systems requirements and audits 13

14 Accomplishments (cont.) Postmarketactivities Use of international standards Adverse event reporting National competent authority exchange program (NCAR) Over 30 guidance documents in use Information exchange for countries developing regulatory systems GHTF training 14

15 GHTF Training Training partners initiative Regional training on GHTF regulatory model NCAR for regulators 15

16 Challenges Regulatory convergence vs. harmonization Uptake and implementation Classification System 3 Classes vs. 4 Classes Conformity Assessment and Type Testing 16

17 Challenges (cont.) US QSR vs. ISO standard Clinical evidence -When is it needed? GHTF training funding, consistency Adoption of global nomenclature 17

18 Why is GHTF s Work Important? Guidelines provide scientifically sound, internationally harmonized means of establishing quality, safety and efficacy Improved transparency, predictability and efficiency of the medical device review process Reduces regulatory burden and promotes industry compliance Harmonized regulatory model for all countries 18

19 Why is GHTF swork Important? (cont.) Promotes trade, innovation and more modern, risk-based approach to regulation Level playing field for industry in all countries Promotes regulatory communication and cooperation Facilitates earlier availability of new devices/technologies Serves to avoid disharmony in technical requirements 19

20 Why is GHTF swork Important? (cont.) Formation of state of art international guidelines based on global perspectives, issues, experience and knowledge Productive working relationships with regulators, organizations and regulated industry Remaining scientifically current Providing leadership internationally 20

21 Adoption of GHTF Model GHTF founding members Asia Asia Harmonization Working Party--liaison member to GHTF ASEAN adoption of GHTF model AHWP participation on study groups Latin America Working toward liaison membership 21

22 Expansion Work with AHWP, Latin American countries, ISO, IEC and others who share the GHTF goals GHTF Training plan Training partners identified Continue APEC training programs Involve other countries Translate guidance documents into other languages Join National Competent Authority Report system (NCAR) Adopt guidance with feedback to GHTF 22

23 The Future is Now GHTF has accomplished much GHTF discussion today leads to the common regulatory framework of tomorrow The time has come to build on this foundation and truly move toward the realization of global harmonization 23