Our International Partnerships in Medicines Regulation Murray M. Lumpkin, M.D., M.Sc. Deputy Commiss

1
Our International Partnerships in Medicines
RegulationMurray M. Lumpkin, M.D., M.Sc.Deputy
CommissionerInternational and Special
ProgramsU.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
21st 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
21st 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
21st 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
  ones own borders

6
21st 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
21st 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
21st Century Reality

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

9
21st 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
FDAs 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
FDAs 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
TOOLS FOR CLOSER BILATERAL COOPERATION
IMPLEMENTATION PLAN
CONFIDENTIALITY ARRANGEMENTS
SPECIFIC POINTS OF CONTACT FOR PUBLIC INFO
15
Confidentiality ArrangementsKey Counterpart
Agencies

• Australia
• Belgium
• Canada
• Denmark
• EU/EMEA
• EU/EFSA
• France
• Germany
• Ireland
• Israel

• Japan
• Mexico
• Netherlands
• New Zealand
• Singapore
• South Africa
• Sweden
• Switzerland
• United Kingdom

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 others 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!