Bridging the Transatlantic Divide – FDA Announces Expanded Cooperation With European Food and Drug Authorities

July 18, 2007

Increasing cooperation between U.S. and European food and drug regulatory authorities are creating efficiencies for regulated industries and that benefit the public health.  In two recent press releases, FDA announced that the European Medicines Agency (“EMEA”) has agreed to expand current regulatory cooperation with the FDA, and that FDA and the European Food Safety Authority (“EFSA”) signed an international cooperation agreement to facilitate the sharing of confidential scientific and other information in the area of food safety, respectively. 

Since the creation of the International Conference on Harmonization in 1990, and the later establishment of the EMEA in 1995, FDA and European drug authorities have sought to harmonize regulatory requirements (where possible).  In September 2003, FDA and EMEA authorities signed a Confidentiality Arrangement that, among other things, identified a number of areas for future cooperation between the two agencies.  Since then, FDA and EMEA have cooperated in various areas, including vaccines, oncology, pharmacogenomics, and with respect to providing parallel scientific advice. 

In June, FDA announced that the EMEA agreed to expand regulatory cooperation under the Confidentiality Arrangement to include pediatrics and orphan drugs.  (In addition, new areas of transatlantic regulatory cooperation are also being discussed, including medical devices and cosmetics.)  Legislation similar to that enacted in the U.S. requiring the study of drugs in pediatric patients and providing data exclusivity was recently enacted in the European Union.  According to a Principles of Interactions document agreed to by both agencies, FDA and EMEA agree:

– to facilitate regular exchange of scientific and ethical issues and other information on pediatric development programmes in Europe and the US to avoid exposing children to unnecessary trials[; and]

– to aim at global pediatric development plans based on scientific grounds, and compatible for both Agencies.

Also, under a revised Implementation Plan for the Confidentiality Arrangement, FDA and EMEA agreed to establish a framework for “upstream regulatory cooperation” on orphan drugs.  Although the Implementation Plan is not specific as to what such orphan drug cooperation would entail, FDA has recently indicated in public talks that the Agency is drafting a guidance document that would describe how companies may submit a single orphan drug designation request to both agencies. 

With respect to food safety, FDA announced on July 2, 2007 that the Agency “signed the first U.S./European agreement in the area of assessing food safety risk.”  The agreement was entered into with EFSA, which was established by the European Parliament in 2002 to perform risk assessment and risk communication on food safety issues.  According to FDA, the agreement:

is designed to facilitate the sharing of confidential scientific and other information between EFSA and the FDA, such as methodologies to ensure that food is safe.  A formal agreement ensures appropriate protection of such confidential information under the applicable legal frameworks in both the United States and the European Union.  Informal cooperation and dialogue have already been established between the two bodies; this agreement will enable these to be formalized and extended.

Given the increasingly global nature of companies regulated by U.S. and European food and drug authorities, and with that, the growing need for a coordinated regulatory plan that improves efficiencies (both for the regulated and the regulators) greater cooperation between FDA and agencies like the EMEA and EFSA, as well as other foreign agencies, will likely continue to increase.        


  • EMEA’s International Cooperation homepage
  • FDA’s International Cooperation homepage

Categories: Miscellaneous