1. Our International Partnerships in Medicines Regulation Murray M. Lumpkin, M.D., M.Sc. Deputy Commissioner International and Special Programs U.S. Food and Drug Administration

2. International Regulatory Cooperation No longer discretionary Integral and pivotal part of the work we and our counterpart agencies perform Only way to accomplish our domestic mission

3. 21 st Century Reality The world in which we operate has radically changed, and continues to do so. Promote and protect public health in the globalized world in which our regulated products are discovered, developed, manufactured, authorized, promoted, marketed, and used by consumers, practitioners and patients.

4. 21 st Century Reality Our borders are now boundaries, NOT barriers –Not barriers to disease –Not barriers to information flow –Not barriers to product acquisition –Are boundaries to our jurisdiction

5. 21 st Century Reality None of us have the financial, human, or scientific resources to do all that our parliaments and people ask and expect of us Cannot meet our mission by only looking within one’s own borders

6. 21 st Century Reality Borders can no longer be the first line of defense – Import Safety Working Group Action Plan; Food Protection Plan We can no longer “inspect” out bad products at the border Borders must be places where we “audit” that indeed quality has been built in at the point of manufacture

7. 21 st Century Reality No national or regional regulatory authority has a monopoly on good science or good regulatory practices. The sum of our parts is clearly superior to their individual value.

8. 21 st Century Reality Regulatory cooperation is no longer discretionary. Regulatory cooperation must become a standard operating procedure of 21 st century flagship medicinal products regulatory authorities

9. 21 st Century Reality We must still respect the great diversity in, and the richness it brings to, the legal, societal, and medical practice foundations upon which each regulatory authority must act within its own jurisdiction.

10. FDA’s Statutory Mission SEC. 903. [ 21 U.S.C. 393] FOOD AND DRUG ADMINISTRATION. (b) MISSION.—The Administration shall— (1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner; (2) with respect to such products, protect the public health by ensuring that— (A) foods are safe, wholesome, sanitary, and properly labeled; (B) human and veterinary drugs are safe and effective; (C) there is reasonable assurance of the safety and effectiveness of devices intended for human use; (D) cosmetics are safe and properly labeled; and (E) public health and safety are protected from electronic product radiation;

11. FDA’s Statutory Mission (3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements;

12. International Cooperative Activities Bilateral and multilateral efforts to leverage the human, scientific, and financial resources of and the knowledge and experience of other key trusted regulatory authorities so as to avoid duplication of effort, to make our activities more efficient, and to allow us to focus our limited resources on higher-risk areas of concern.

13. Increased Bilateral Cooperation Increase the efficiency and impact of information and human resource exchange –Focus on specific information –Focus of timing of exchange –Institutionalize the processes Formal Informal - Peer sounding boards

14. “The Pyramid” CONFIDENTIALITY ARRANGEMENTS IMPLEMENTATION PLAN TOOLS FOR CLOSER BILATERAL COOPERATION SPECIFIC POINTS OF CONTACT FOR PUBLIC INFO

15. Confidentiality Arrangements: Key Counterpart Agencies Japan Mexico Netherlands New Zealand Singapore South Africa Sweden Switzerland United Kingdom Australia Belgium Canada Denmark EU/EMEA EU/EFSA France Germany Ireland Israel

16. Confidentiality Arrangements Legal Framework –Commercial confidential –Pre-decisional –Investigative – compliance –NOT Trade Secret –NO requirement to exchange anything

17. Implementation Plans Depends on country and issues being addressed – level of capability, history of interactions, level of confidence None is more robust or active than ours with the EU and EMEA on medicinal products Work in many arenas – multilaterally –ICH, VICH, GHTF, ICRR, WHO

18. Implementation Plans The European Commission and the EMEA are two of our most important counterpart agencies and the ones with whom we feel we have one of the most developed, most bilaterally productive relationships – personally, professionally, and organizationally.

19. Implementation Plans These arrangements form the framework for our almost daily interactions with our European counterparts on these products, and they help focus attention on those areas we have agreed for more intense work during the year.

20. Implementation Plans We meet formally with our European colleagues at least once a year (at which the work plan for the next year is agreed), and we meet with them informally innumerable times each year in person, on the telephone, or in cyberspace.

21. Implementation Plans “Clusters” – Pediatrics, vaccines, pharmacogenomics, oncology, orphans, product safety –Monthly (if not more often) telephone conferences about specific issues and products during which they leverage each other's scientific perspective and insight and regulatory resources.

22. History 12 Sept 2003 – Confidentiality Arrangements 16 Sept 2004 – Implementation Plan 17 Sept 2004 – Guidance on Parallel Scientific Advice 12 Sept 2005 – Confidentiality Arrangements extended to 2010 21 May 2006 – Voluntary Genomics Data Submissions Guidance 02 July 2007 – Arrangements on medical devices and cosmetics 02 July 2007 – Implementation Plan Updated October 2007 – Joint Orphan Products Designation Form

23. Regulatory Cooperation between EC and US FDA Ad-hoc upstream regulatory cooperation –Non papers on regulatory issues prior to the drafting of new legislation or regulations –Advance drafts of legislation in the EU and advance drafts of regulations in the US –Implementing technical texts such as guidelines –Staff exchanges –Bilateral meetings and workshops

24. Regulatory Cooperation between EMEA and the US FDA Regular information exchanges – Quarterly: newly submitted MAAs, MAAs still undergoing review, MAAs on which a marketing decision has been made that quarter and what the decision was (for post-authorization applications, limited to major public health interest such as new indications or important safety concerns

25. Regulatory Cooperation between EMEA and the US FDA Regular information exchanges –Listings of GCP inspections performed since last report and likely to be performed –As requested, pharmacovigilance inspection reports –GMP – access to COMSTAT and EudraGMP

26. Regulatory Cooperation between EMEA and the US FDA Ad-hoc exchanges –Emergency information (usually related to safety/public health or major news impact) –Urgent Requests (data to be provided in 24 hours) –Expedited Requests (4 working days) –Standard Requests (2 weeks)

27. Regulatory Cooperation between EMEA and the US FDA Ad-hoc exchanges –Parallel Scientific Advice Programme –Issues with specific MAAs not covered by the regular exchanges –Product-specific pharmacovigilance issues (especially black boxes or more stringent regulatory actions / changes affecting product licensing status and resulting in public information)

28. Regulatory Cooperation between EMEA and the US FDA Ad-hoc exchanges –Actions to restrict distribution that may have an impact on each other’s market –Issues of general public interest (BSE, counterterrorism)

29. FDA Presence outside USA Believe it is necessary to help make our interactions with counterparts more useful Full time focus on these relationships Bilaterally helpful – a win/win China, India, Europe, Middle East, Latin America

30. THANK YOU!