The European Medicines Agency (EMA) will establish and maintain an EU PAS Register for registration of non-interventional PASS, as described in GVP chapter VIII.B.4.
This EU PAS Register will be an upgrade of the existing ENCePP E-Register of Studies. Before the EU PAS Register is fully operational, studies should be registered in the ENCePP E-Register of Studies to comply with GVP.
Related information:
- Good Pharmacovigilance Practices (link to EMA website)
Details
- Publication date
- 17 October 2012
- Author
- European Medicines Agency