22/23 February 2024
At the end of last year, the EDQM updated the following four guidelines. Those guidelines contain provisions for new applications for a Certificate of Suitability (CEP) as well as for the revision or renewal of a CEP:
You can read here a brief summary of the contents and changes made to the documents:
The "sister file" procedure facilitates the submission of another CEP application for an API for which a CEP has already been issued. The new CEP can, for example, be used for the same API but with an alternative specification. Such application procedures are usually less bureaucratic and can be processed more quickly.
The revised guidance takes into account various cases in which the "sister file" procedure is possible or not and also makes reference to the ICH guidelines Q11 Q&A, Q3D and M7.
There is a new application form for the "sister file" procedure.
In this revised guidance, the processing period for a "sister file" procedure was shortened from 3 to 2 months and thus aligned with the processing period for a "major revision". This is the only change in this document. A new application form has also been assigned to it.
This Guideline also takes into account - as does the first Guideline above - cases where a separate application must be submitted, for example when a significantly different synthesis route with otherwise the same impurity profile or different production sites do not belong to the same group. A separate application procedure is also required in the event that raw material is obtained from different sources with different TSE risks. The ICH Q11 Q&A, Q3D and M7 guidelines are also considered in this document.
These updated guidelines have a significant impact on the regulatory strategy of a marketing authorisation procedure. The EDQM therefore strongly recommends that applicants consider them in order to avoid unnecessary delays in the application process.
All four revised Guidelines have been in force since the beginning of 2019.