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

EMA has published a guideline on the minimum data content SMEs should submit when seeking certification of quality and non-clinical data:

How to apply

To notify the Agency of an upcoming ATMP certification request, complete the form below and return it to pa-bus@ema.europa.eu:

To submit a request for ATMP certification, complete the certification request form and attachment sheet below and send via Eudralink to pa-bus@ema.europa.eu, together with the annexes and application dossier for certification:

After validation, re-submit the ATMP certification dossier together with the annexes via Eudralink to pa-bus@ema.europa.eu and to the CAT members.

All applications have to be submitted in English.

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*
13/07/2018 21/08/2018 31/08/2018 24/09/2018 01/10/2018 05/10/2018 12/10/2018 09/11/2018
10/08/2018 18/09/2018 28/09/2018 22/10/2018 29/10/2018 05/11/2018 09/11/2018 07/12/2018
20/08/2018 28/09/2018 08/10/2018 19/11/2018 26/11/2018 30/11/2018 07/12/2018 25/01/2019
08/10/2018 16/11/2018 26/11/2018 07/01/2019 14/01/2019 18/01/2019 25/01/2019 22/02/2019
31/10/2018 11/12/2019 21/12/2018 04/02/2019 11/02/2019 15/02/2019 22/02/2019 22/03/2019
10/12/2018 18/01/2019 28/01/2019 04/03/2019 11/03/2019 15/03/2019 22/03/2019 17/04/2019
21/12/2018 05/02/2019 15/02/2019 01/04/2019 08/04/2019 12/04/2019 17/04/2019 24/05/2019
04/02/2019 15/03/2019 25/03/2019 06/05/2019 13/05/2019 17/05/2019 24/05/2019 21/06/2019
27/02/2019 05/04/2019 17/04/2019 03/06/2019 10/06/2019 14/06/2019 21/06/2019 19/07/2019
01/04/2019 10/05/2019 20/05/2019 01/07/2019 08/07/2019 12/07/2019 19/07/2019 16/08/2019
27/05/2019 05/07/2019 15/07/2019 26/08/2019 02/09/2019 06/09/2019 13/09/2019 11/10/2019
12/07/2019 20/08/2019 30/08/2019 23/09/2019 30/09/2019 04/10/2019 11/10/2019 08/11/2019
09/08/2019 17/09/2019 27/09/2019 21/10/2019 28/10/2019 31/10/2019 08/11/2019 06/12/2019
19/08/2019 27/09/2019 07/10/2019 18/11/2019 25/11/2019 29/11/2019 06/12/2019 24/01/2020
11/10/2019 19/11/2019 29/11/2019 06/01/2020 13/01/2020 17/01/2020 24/01/2020 21/02/2020
04/11/2019 13/12/2019 23/12/2019 03/02/2020 10/02/2020 14/02/2020 21/02/2020 20/03/2020
02/12/2019 10/01/2020 20/01/2020 02/03/2020 09/03/2020 13/03/2020 20/03/2020 24/04/2020
06/01/2020 14/02/2020 24/02/2020 06/04/2020 14/04/2020 17/04/2020 24/04/2020 20/05/2020
30/01/2019 10/03/2019 20/03/2019 04/05/2020 11/05/2020 15/05/2020 20/05/2020 19/06/2020
02/03/2020 10/04/2020 20/04/2020 02/06/2020 08/06/2020 12/06/2020 19/06/2020 17/07/2020
30/03/2020 08/05/2020 18/05/2020 29/06/2020 06/07/2020 10/07/2020 17/07/2020 14/08/2020
25/05/2020 03/07/2020 13/07/2020 24/08/2020 31/08/2020 04/09/2020 11/09/2020 09/10/2020

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

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