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FDA and EU (European Commission and EMEA) Extend Confidentiality Arrangements for Five More Years

The U.S. Food and Drug Administration (FDA), European Commission (EC), and European Medicines Agency (EMEA) have extended their confidentiality arrangements related to medicinal products for human and veterinary use for five more years, following the positive experience gained since the initial arrangements were signed in September 2003.

The confidentiality arrangements allow FDA and EC/EMEA to exchange information as part of their regulatory processes.  The types of information covered by the arrangements include legal and regulatory issues, scientific advice, orphan drug designation, inspection reports, marketing authorization procedures, and post-marketing surveillance.

NOTES:

1. September 2003 public statement and Exchange of Letters between the FDA, European Commission, and EMEA

2. Implementation plan for the confidentiality arrangements as regards medicinal products for human use, agreed and published in .

3. A pilot programme allowing companies to obtain parallel scientific advice from the two agencies for the development of medicinal products for human use was part of the first phase of implementation.  General principles document.

4. The confidentiality arrangements cover medicinal products that are subject to evaluation or authorized under the centralized procedure, as well as medicinal products that are authorized at the national level by the EU Member States and that are subject to official European Community arbitrations and referrals.

5. More information on the work of the three bodies can be found on the Internet:

FDA
European Commission's Pharmaceutical Unit
European Medicines Agency

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