Regulatory information - European Medicines Agency publishes guidance on validation process for initial marketing authorisation

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05/08/2013

Regulatory information - European Medicines Agency publishes guidance on validation process for initial marketing authorisation

The European Medicines Agency (EMA) has updated its pre-authorisation procedural advice for users of the centralised procedure to outline the most common mistakes detected by the Agency during the validation of initial marketing-authorisation applications and provides guidance on how to avoid them. This document is intended to help applicants complete their submissions correctly and avoid any delays in the validation process.

The issues are classified in different categories:

  • good manufacturing practice (GMP);
  • good clinical practice (GCP);
  • paediatrics;
  • quality;
  • non-clinical and clinical.

Initial marketing-authorisation applications must receive a positive validation outcome in order for a procedure to start on the next available start date in the EMA submission timetable. The validation aims to ensure that all essential regulatory elements required for scientific assessment are included in the application and in line with the chosen legal basis.

The question-and-answer document explains the aim, principles and individual stages of the validation process. It also clarifies the validation timeline.

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