CEP 2.0: Insights into Inspection Reports

As part of the implementation of the new "CEP 2.0", the EDQM (European Directorate for the Quality of Medicines & HealthCare) has now published on its website a list of authorities and organizations that have insight into the inspection and assessment reports. With these parties there is either a confidentiality agreement or/and a memorandum of understanding.

Authorities and organizations that have access to both reports (inspection and assessment reports) include, for example, the Brazilian health authority ANVISA as well as the Saudi Arabian health authority SFDA and the WHO.

In contrast, only insights into the inspection reports are available to the following organizations and authorities:

• PIC/S, Switzerland 
• MHLW, Japan 
• USFDA, USA

The full list of eligible parties can be found on the EDQM website.

Furthermore, reference is again made here to the new requirements for CEP dossiers implemented on 01 June 2023. In a summary, these new requirements are listed and explained, as well as provided with further information and links.

There is also a link to the basic information on the structure and content of the CEP 2.0, as reported in a news in April.