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EMA Guidance: Pre-Authorisation Procedural Advice for Users of the Centralised Procedure

Last Friday (29 September 2023) the European Medicines Agency released an updated guidance on "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure".

The European Medicines Agency (EMA) plays a pivotal role in ensuring the safety, quality, and efficacy and For pharmaceutical companies and stakeholders seeking to bring their products to the EU market, understanding and following the EMA's pre-authorisation procedural advice is paramount.

Pre-authorization procedural advice from the EMA is an important resource for pharmaceutical companies and applicants participating in the centralized procedure. In addition to serving as a roadmap, it guides applicants through the regulatory landscape and assists them in preparing their marketing authorization applications (MAAs).

This guidance offers valuable insights and recommendations, covering various aspects of the application process, such as

  • Scientific Advice:

  • Quality Requirements

  • Non-Clinical and Clinical Data

  • Orphan Designation

  • Pediatric Investigation Plans (PIPs)

  • Risk Management Plans (RMPs)

By following this guidance, applicants can enhance the efficiency of their applications, ensure compliance with EU regulatory standards, and ultimately contribute to faster access to safe and effective medicines for patients across the European Union.


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