Since conducting a wide public survey on the Certification of suitability to the European Pharmacopoeia monographs (CEP), the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been working on the design of the CEP of the future. Different aspects were presented to stakeholders at three targeted consultation workshops in September 2022. The first was for authorities from European Pharmacopoeia member states, the second was for authorities in non-Ph. Eur. member states that accept CEPs, and the third was for industry stakeholders. Each workshop was organised to gather feedback on specific outstanding questions.
The EDQM’s CEP of the future project team will analyse the feedback received during these discussions with the decision-making bodies to fine tune the design of the CEP of the future. The EDQM will then initiate a large communication campaign to explain the proposed changes.