FDA and EU Extend Confidentiality Arrangements

GMP News No. 642

GMP News
1 December 2005

FDA and EU Extend Confidentiality Arrangements

FDA, EU Commission and EMEA have prolonged the confidentiality arrangements concluded in September 2003 by another 5 years. The arrangements concern both medicinal products for human and for veterinary use.

The arrangements allow FDA and EU/EMEA to exchange information gathered in their respective regulatory development processes. They include the following items:

  • legal and regulatory issues
  • inspection reports (!)
  • marketing authorisation procedures

You can download the original arrangements of September 2003 here. The implementation plan for the arrangements can be downloaded here

Source: http://www.fda.gov/bbs/topics/news/2005/NEW01257.html

Compiled by
Oliver Schmidt
on behalf of ECA

Go back

GMP Conferences by Topics