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Diplomacy in Action

Framework for Promoting Transatlantic Economic Integration, Annex I: Fostering Cooperation and Reducing Regulatory Barriers, B. Sectoral Cooperation--Medicinal Products


Bureau of European and Eurasian Affairs
January 24, 2010

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Points of Contact

European Commission:
Matus Ferech, DG ENT
Email: Matus.Ferech@ec.europa.eu
Telephone:
U.S. Government:
Murray Lumpkin, FDA
Email: murray.lumpkin@fda.hhs.gov
Telephone:+1 301 827 5709
EU Delegation in Washington:
(name)
Email:
Telephone:
U.S. Mission to the EU:
Linda Tollefson, FDA
Email: TollefsonLR@state.gov
Telephone: +32 (2) 508-2164



Reference
Framework, Annex 1, B.3 (c).

Goal

To eliminate unnecessary regulatory divergences in the regulation of medicinal products.

Specific Objectives

1. Promote administrative simplification in the marketing authorization process for medicinal products.
2. Convergence in Orphan Drug designation and regulation to the extent possible.
3. Collaboration on inspections of facilities manufacturing active pharmaceutical ingredients, especially in third countries.

Progress

General: The U.S. Food and Drug Administration (FDA)-and the European Medicines Agency (EMA) collaborate robustly in a number of medicinal product areas, under the confidentiality arrangements between the EC, EMA and FDA:

  • Routine “cluster” meetings and other collaborations, used for on-going discipline-specific issues. Usually occur monthly or more often if needed (e.g., vaccine products for H1N1 influenza has been meeting 3-4 times a week during the height of the pandemic), to address scientific and regulatory issues. Current cluster meetings include oncology products, orphan products, pediatrics, pharmacovigilance (includes risk management issues), vaccines, pharmacogenetics, and veterinary pharmaceuticals. The Office of Pediatric Therapeutics of the FDA and the National Institute of Child Health and Human Development hosted an international workshop from September 21-23, 2009 to address ethical and regulatory issues in global pediatric clinical trials. EMA and EC were active participants, as were representatives of several EU member state national drug regulatory authorities and ethicists and clinical trialists from the USA, the EU, and other parts of the world. Follow up initiatives have been identified based on the outcomes of this workshop.
  • As-needed meetings, to address urgent requests for information on products or policies.
  • Frequent short-term exchanges of scientific staff between EMEA and FDA.
  • The EC/EMEA/FDA annual formal bilateral meeting took place on September 27-30 in the U.S.

In addition, FDA has initiated a permanent presence in China, India, Latin America the Middle East, and Europe. The focus of the Europe Office is enhancement of our collaboration with the European Union and leveraging of resources.

  • Director of FDA Europe Office located in Brussels at the U.S. Mission to the EU.
  • Deputy Director for Medical Products located at EMEA in London, as of July 1, 2009.
  • Deputy Director for Foods to be located at the European Food Safety Authority (EFSA) in Parma, Italy.

The EMA and EFSA positions are exchanges; both an EFSA and an EMA senior staff member are now seconded to FDA for at least two years. This permanent embedding of senior scientists at each other’s further augments the opportunities for collaboration in the food area as well as medicinal products.

1. Administrative Simplification: U.S. and EU agreed to a Medicines Regulation Transatlantic Administrative Simplification Action Plan in June 2008.

On June 17, 2008 the U.S. FDA, the EMA and the EC adopted the Transatlantic Administrative Simplification Action Plan with projects spanning 18 different areas including: inspections, biosimiliars, scientific advice, and counterfeiting. The Commission tabled a pharmaceutical legislative proposal in December 2008 on Information to Patients and on combating counterfeiting.

In addition, EMA and FDA have established a mechanism to permit parallel scientific advice at which sponsors and assessors can exchange views on scientific issues during the development phase of new human drugs and biologics.

  • Particularly helpful for new products for which development guidelines do not exist or EMA’s and FDA’s guidelines differ significantly.
  • Prime candidates are orphan indications, pediatric populations or breakthrough medicinal products, especially where clusters are already established and staff in both agencies are well acquainted with each other.
  • Each agency provides independent advice to the sponsor on the questions posed.
  • Sponsors should neither expect similar recommendations on drug development issues nor expect to receive similar decisions on the applications, but such discussions could lead to the possibility of less divergence in approach and outcome, and clearly will lead to all three parties (FDA, EMA, and sponsor) understading much better the perspectives and needs of the others.
  • The latest report (October 2009) on the Transatlantic Administrative Simplification Action Plan can be found at http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/EuropeanUnion/EuropeanUnion/EuropeanCommission/ucm114345.htm

2. Orphan Drugs: Completed. Developed a uniform application form for designation of orphan products to be used by both EMA and FDA. This cluster is now working on other areas where regulatory convergence could be possible.

3. Joint Active Pharmaceutical Ingredient Inspections Pilot began November 2008 and involves EMA, FDA, Australia’s Therapeutic Goods Administration, and (as coordinated by EMA - regulatory authorities from Germany, France, Ireland, UK and the European Directorate for the Quality of Medicines and Health Care (EDQM).

  • This is a program of coordinated inspections with goal to reduce international duplication of inspections and allow participants to gain information on more sites in third countries.
  • Initially for simultaneous inspections; goal is to rely on other agency’s inspection findings in making regulatory or future inspectional decisions.
  • Reference GMP standard for the inspections is ICH Q7: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients – a guidance upon which all participating agencies have already agreed.

Next Steps

  • Continue holding cluster and as-needed meetings to discuss scientific and regulatory issues.
  • Place FDA Staff in Parma.
  • In planning stages for Joint Good Clinical Practice Inspections Pilot, to be modeled after the Joint API Inspections Pilot
  • Reassess the Parallel Scientific Advice program.
  • Monitor EU's decision making process regarding pharmaceutical legislation.
  • Assess the impact of the move of the pharmaceuticals sector from DG Enterprise to DG SANCO
  • Confidentiality arrangement due for renewal in 2010.



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