Marketing-authorisation procedures for advanced-therapy medicinal products

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The European Medicines Agency (EMA) provides procedural and guidance documents to help companies applying for a marketing authorisation for advanced therapy medicinal products (ATMPs). 

For queries specifically om the authorisation of ATMPs, write to advancedtherapies@ema.europa.eu.

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Procedural advice on the evaluation of ATMPs (updated)

In January 2018, EMA updated its procedural advice on the evaluation of ATMPs:

The aim of the update is to clarify the evaluation procedure, to help developers of these medicines navigate the regulatory process in the European Union. The updated guidance:

  • reinforces timely and effective interactions between the applicants, EMA and its committees;
  • details the roles and responsibilities of the three of EMA’s scientific committees involved in the evaluation: the Committee on Advanced Therapies (CAT), the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC);
  • streamlines the processes for adopting the list of questions and list of issues by the committees;
  • clarifies in which situations oral explanations might be needed;
  • gives developers more time to respond to questions raised by the Committees by allowing longer clock stops.

This guidance concentrates on the initial evaluation of new ATMPs, but its principles also apply to post-authorisation procedures.

For more information on the changes introduced by the updated guidance, see:

The PRAC, the CAT and the CHMP adopted the updated guidance at their December 2017 meetings. 

This is part of the joint action plan of the European Commission and EMA to streamline procedures and better address the specific requirements of ATMP developers. For more information, see Advanced therapies: overview.

Dossier requirements and submission dates

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Document(s) Language Status First published Last updated Effective Date
Dossier requirements for centrally authorised products (English only)   2009-06-26 2017-02-24  

Guideline on the risk-based approach according to Annex I, part IV of Directive/2001/83/EC applied to advanced therapy medicinal products

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Procedural advice on the re-examination of Committee for Medicinal Products for Human Use opinion

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Document(s) Language Status First published Last updated Effective Date
Procedural advice on the re-examination of CHMP opinions (English only) draft: consultation closed 2009-02-12    

Procedural advice on the consultation of notified bodies in the case of a combined ATMPs

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Archive: Draft procedural advice on the evaluation of ATMPs

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Document(s) Language Status First published Last updated Effective Date
Draft procedural advice on the evaluation of advanced therapy medicinal products in accordance with article 8 of Regulation (EC) No 1394/2007 (English only) draft: consultation closed 2009-03-31