European Medicines Agency Pre-Authorization Procedural Advice for Users of the Centralized Procedure

20 June 2022 — EMA published updated pre-authorization Q&A guidance.

This guidance document addresses a number of questions which users of the centralized procedure may have. It provides an overview of the European Medicines Agency’s position on issues, which are typically addressed during the course of pre-submission meetings.

The following sections were revised:

  • 3.3.3. What information regarding transfer of test methods is required for different active substance or finished product release testing sites in the MAA? Rev. Jun 2022
  • 5.1.1. How long does it take for my application to be evaluated? Rev. Jun 2022
  • 5.1.11. Can EMA assessment or inspection documents be shared with third parties? Rev. Jun 2022
  • 5.2.1. When can I expect a pre-authorization GMP inspection and how are they conducted? Rev. Jun 2022
  • 5.2.2. When can I expect a pre-approval GCP inspection and how are they conducted? Rev. Jun 2022
  • 5.2.3. What is the fee for a GMP/GCP/GLP pharmacovigilance inspection? Rev. Jun 2022
Read the pdf 
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