EDQM: New CEP 2.0

Recommendation

6/7 September 2023
Vienna, Austria

Drug Master File Procedures in the EU, the US and Japan
Taking into account the guidance on metal impurities (ICH Q3D) and genotoxic impurities (ICH M7)

The formerly named "CEP of the future" is now named "CEP 2.0", as recently reported on the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare). The new design of the CEP shall support stakeholders in handling CEPs and shall increase the transparency of the provided information.

Now, after the public consultation in 2020 and further targeted consultations in 2022, the "Certification Steering Committee" made a decision on the new design of the CEP. The implementation is expected to take place in 2023 and will be relevant for CEP holders, CEP applicants as well as CEP users. The following 9 sections list the areas, in which changes will be expected:

• Area 1: CEPs and information reported
• Area 2: Changes regarding assessment of CEP applications
• Area 3: On-line public certification database
• Area 4: Authorities Database
• Area 5: Fostering information sharing between CEP holders & MAH
• Area 6: Reduction of revisions of CEPs
• Area 7: Impact of changes and their implementation
• Area 8: Trainings for assessors, CEP holders and CEP users
• Area 9: Revising documents available on the website

Every section includes a brief explanation, what this area will look like in the future as well as which changes will occur. Additionally, some of these areas list which documents need to be updated and give examples how the new system will be.

For further information please visit the website of the EDQM in the section of "CEP 2.0".