Survey - Certificates of Suitability

Category: IPEC Europe
  • 4 May 2022

EDQMs’ Certificates of Suitability (CEPs) can be granted on a voluntary basis for materials which are the subject of monographs in the European Pharmacopoeia. CEPs are granted for specific substances which does not differentiate API vs excipient applications; known only to the finished drug product manufacturer.

CEPs are often used globally by drug product manufacturers in marketing authorisation applications (MAA) but are often misunderstood by the drug product manufacturers or regulator. This can lead to data requests to support CEP and MA applications appropriate for an API but not an excipient, where the same type of information is not routinely available.

Moreover, in some cases, it has been reported that CEPs have been used for other purposes, which we also intend to capture through this survey.

To better understand the scale of this issue and which direction IPEC Europe could take, we would be extremely grateful if you could answer the 5-8 questions (approx. 10 minutes) in this anonymous and confidential survey by 11 May 2022.

Access the Survey

Please do not hesitate to share the link to this survey with your internal and external network!

We sincerely appreciate your support.

On behalf of the IPEC EU CEP Task Force team.