European Medicines Agency and U.S. Food and Drug Administration extend confidentiality arrangements indefinitely
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have extended their confidentiality arrangements related to medicinal products for human and veterinary use, following the positive experience gained since the initial arrangements were signed in September 2003. This cooperation will now continue indefinitely without the need for further renewal.
The confidentiality arrangements allow both Agencies to exchange confidential information as part of their regulatory and scientific processes. Their aim is to promote public and animal health and to protect European and U.S. patients. The types of information covered by the arrangements relate to scientific advice, orphan drug designation, paediatric development, good manufacturing practice (GMP) and good clinical practice (GCP) inspection planning and reports, marketing authorisation procedures and subsequent changes to the marketing authorisations together with post-marketing surveillance.
The confidentiality arrangements cover medicines that are subject to evaluation or authorised under the centralised procedure as well as medicines that are authorised at national level by the EU Member States and that are subject to official European Community arbitrations and referrals.
These new commitments are based on the achievements of the previous arrangements between the EMA, the European Commission and the FDA.
The current implementation plan remains in force.
|Name||Language||First published||Last updated|
|European Medicines Agency and U.S. Food and Drug Administration extend confidentiality arrangements indefinitely||(English only)||15/09/2010|
- Statement of authority and confidentiality commitment from the European Medicines Agency not to publicly disclose non-public information shared by the United States Food and Drug Administration (15/09/2010)
- Statement of authority and confidentiality commitment from the United States Food and Drug Administration not to publicly disclose non-public information shared by the European Medicines Agency (15/09/2010)
- Public statement on EU-US FDA bilateral meeting 12 September 2003
- More on the Agency's confidentiality arrangements with the FDA
- U.S. Food and Drug Administration (FDA)
Monika Benstetter or Sabine Haubenreisser
Tel. +44 (0)20 7418 8427