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
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