Procedural Advice – Extended Assessment Time for Initial Marketing Authorization Applications of 90 Days

On 25 February 2022 the EMA published the extended assessment time for initial marketing authorization applications.

For the majority of scientific evaluations of centralized marketing authorization applications, the rapporteurs and their supporting assessment teams will have in-depth scientific knowledge and experience in the relevant scientific areas. However, in order to provide the highest level of relevant expertise, it is occasionally necessary to seek expertise from outside the allocated assessment teams, which can be a time consuming process, in particular if such a request occurs ad-hoc. In order to facilitate the assessment by the CVMP in such cases, Regulation (EU) 2019/6 has introduced a provision to exceptionally extend the standard timeframe for an initial assessment procedure by a maximum of 90 days in cases where particular expertise is required.

This document outlines the criteria for such “particular expertise”, as well as the procedural steps to take into account when deciding on the use of such additional time.

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