Marketing-authorisation procedures for advanced-therapy medicinal products

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 on the authorisation of ATMPs, write to

Procedural advice on the evaluation of ATMPs

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:

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.

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

Core SmPC, labelling and package leaflet for ATMPs containing genetically modified cells

  • List item

    Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells (PDF/465.69 KB)


    First published: 26/10/2022

  • List item

    ATMP product information template version 1 (DOCX/75.47 KB)

    First published: 28/09/2022

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


How useful was this page?

Add your rating
1 rating
5 ratings
2 ratings
1 rating
6 ratings