Certification procedures for micro-, small- and medium-sized enterprises (SMEs)

The European Medicines Agency's Committee for Advanced Therapies (CAT) provides a certification procedure for advanced therapy medicinal products (ATMPs) under development by micro-, small- and medium-sized enterprises (SMEs). This is an opportunity for SMEs to get an assessment of the data they have generated and check that they are on the right track for successful development.

The certification procedure involves the scientific evaluation of quality data and, when available, non-clinical data that SMEs have generated at any stage of the ATMP development process. It aims to identify any potential issues early on, so that these can be addressed prior to the submission of a marketing-authorisation application.

After assessment, the CAT may recommend issuing a certification confirming the extent to which the available data comply with the standards that apply for evaluating a marketing-authorisation application. Following the CAT recommendation, the Agency issues a certification.

The evaluation and certification procedure takes 90 days.

The certification procedure is defined in Article 18 of Regulation (EC) No 1394/2007 (the 'ATMP Regulation').

Procedural advice

EMA has published guidance to SMEs on the procedures, timelines and practical steps for the submission, evaluation and certification of quality and non-clinical data:

Guideline on the minimum quality and non-clinical data

How to apply

Applications need to be submitted in English via EMA Service Desk.

If you do not have an EMA account, please create one using the EMA Account Management portal.

In EMA Service Desk, please select 'Pre-submission phase request' under ‘Type of question’, followed by 'ATMP certification' to submit your request.

To notify EMA of an intention to submit an ATMP certification request, complete the ‘Intent to submit’ pre-submission request form below and submit it via EMA service desk:

To request an ATMP certification, complete the ‘ATMP certification’ pre-submission request form and list of annexes below and send these together with all the annexes composing the ATMP certification dossier via EMA service desk:

After validation, re-submit the ATMP certification dossier via Eudralink to the CAT members and via EMA service desk.

Submission deadlines

Submission of draft application Submission of final application Start of procedure Coordinator's evaluation report Comments for CAT members and peer reviewers Consolidated evaluation report Discussion at CAT (day 60) CAT adoption of opinion*
29/03/2021 07/05/2021 17/05/2021 28/06/2021 05/07/2021 09/07/2021 16/07/2021 13/08/2021
28/05/2021 06/07/2021 16/07/2021 23/08/2021 30/08/2021 03/09/2021 10/09/2021 08/10/2021
02/07/2021 10/08/2021 20/08/2021 20/09/2021 27/09/2021 01/10/2021 08/10/2021 05/11/2021
30/07/2021 07/09/2021 17/09/2021 18/10/2021 25/10/2021 29/10/2021 05/11/2021 10/12/2021
23/08/2021 01/10/2021 11/10/2021 22/11/2021 29/11/2021 03/12/2021 10/12/2021 21/01/2022
04/10/2021 12/11/2021 22/11/2021 03/01/2022 10/01/2022 14/01/2022 21/01/2022 18/02/2022
03/11/2021 10/12/2021 22/12/2021 31/01/2022 07/02/2022 11/02/2022 18/02/2022 18/03/2022
03/12/2021 11/01/2022 21/01/2022 28/02/2022 07/03/2022 11/03/2022 18/03/2022 13/04/2022
22/12/2021 07/02/2022 17/02/2022 28/03/2022 04/04/2022 08/04/2022 13/04/2022 13/05/2022
24/01/2022 04/03/2022 14/03/2022 25/04/2022 02/05/2022 06/05/2022 13/05/2022 17/06/2022
23/02/2022 01/04/2022 13/04/2022 30/05/2022 07/06/2022 10/06/2022 17/06/2022 15/07/2022
28/03/2022 06/05/2022 16/05/2022 27/06/2022 04/07/2022 08/07/2022 15/07/2022 12/08/2022
25/05/2022 05/07/2022 15/07/2022 22/08/2022 29/08/2022 02/09/2022 09/09/2022 07/10/2022
01/07/2022 09/08/2022 19/08/2022 19/09/2022 26/09/2022 30/09/2022 07/10/2022 04/11/2022
29/07/2022 06/09/2022 16/09/2022 17/10/2022 24/10/2022 28/10/2022 04/11/2022 09/12/2022
26/08/2022 04/10/2022 14/10/2022 21/11/2022 28/11/2022 02/12/2022 09/12/2022 20/01/2023
07/10/2022 15/11/2022 25/11/2022 02/01/2023 09/01/2023 13/01/2023 20/01/2023 17/02/2023
04/11/2022 14/12/2022 24/12/2022 30/01/2023 06/02/2023 10/02/2023 17/02/2023 24/03/2023
05/12/2022 13/01/2023 23/01/2023 06/03/2023 13/03/2023 17/03/2023 24/03/2023 21/04/2023
02/01/2023 10/02/2023 20/02/2023 03/04/2023 11/04/2023 14/04/2023 21/04/2023 17/05/2023
27/01/2023 07/03/2023 17/03/2023 02/05/2023 08/05/2023 12/05/2023 17/05/2023 16/06/2023
27/02/2023 05/04/2023 17/04/2023 30/05/2023 05/06/2023 09/06/2023 16/06/2023 14/07/2023
27/03/2023 05/05/2023 15/05/2023 26/06/2023 03/07/2023 07/07/2023 14/07/2023 11/08/2023

*Provided that there is no need for written or oral explanation.

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