Certification procedures for advanced therapies under development by micro-, small- and medium-sized enterprises (SMEs)
HumanAdvanced therapiesRegulatory and procedural guidanceResearch and developmentSME
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:
- Procedural advice on the certification of quality and non-clinical data for small and medium-sized enterprises developing advanced therapy medicinal products
- Overview of comments received on procedural advice on the certification of quality and non-clinical data for small and medium-sized enterprises developing advanced therapy medicinal products
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
Applications need to be submitted in English via EMA Service Desk, selecting the tab 'Business Services', category 'Human Regulatory'. The subcategory to be selected is 'Pre-Submission Phase - Human', followed by the sub-option 'ATMP Certification Request'.
If you do not have an EMA account, please create one using the EMA Account Management portal. For further information or guidance about how to create an EMA Account reference the guidance 'Create an EMA Account'.
To notify EMA of an intention to submit an ATMP certification request, the 'Intent to submit' pre-submission request form below must be included in your request:
To request an ATMP certification, the 'ATMP certification' pre-submission request form and all the annexes composing the ATMP certification dossier must be included in your request:
- Presubmission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application
- Annexes to the application form for certification of quality and non-clinical data for Advanced Therapy Medicinal Products developed by Small and Medium-sized Enterprises (SME)
After validation, re-submit the ATMP certification dossier via Eudralink to the CAT members and via EMA service desk, selecting the tab 'Business Services', category 'Human Regulatory'. The subcategory to be selected is 'Pre-Submission Phase - Human', followed by the sub-option 'ATMP Certification Request'.
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* |
|---|---|---|---|---|---|---|---|
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 |
30/05/2023 | 07/07/2023 | 18/07/2023 | 21/08/2023 | 28/08/2023 | 01/09/2023 | 08/09/2023 | 06/10/2023 |
03/07/2023 | 11/08/2023 | 21/08/2023 | 18/09/2023 | 25/09/2023 | 29/09/2023 | 06/10/2023 | 31/10/2023 |
26/07/2023 | 01/09/2023 | 13/09/2023 | 13/10/2023 | 20/10/2023 | 24/10/2023 | 31/10/2023 | 08/12/2023 |
21/08/2023 | 29/09/2023 | 09/10/2023 | 20/11/2023 | 27/11/2023 | 01/12/2023 | 08/12/2023 | 19/01/2024 |
12/10/2023 | 20/11/2023 | 30/11/2023 | 02/01/2024 | 08/01/2024 | 12/01/2024 | 19/01/2024 | 16/02/2024 |
09/11/2023 | 18/12/2023 | 28/12/2023 | 29/01/2024 | 05/02/2024 | 09/02/2024 | 16/02/2024 | 15/03/2024 |
28/11/2023 | 05/01/2024 | 16/01/2024 | 26/02/2024 | 04/03/2024 | 08/03/2024 | 15/03/2024 | 19/04/2024 |
02/01/2024 | 09/02/2024 | 20/02/2024 | 02/04/2024 | 08/04/2024 | 12/04/2024 | 19/04/2024 | 24/05/2024 |
07/02/2024 | 17/03/2024 | 27/03/2024 | 06/05/2024 | 13/05/2024 | 17/05/2024 | 24/05/2024 | 21/06/2024 |
04/03/2024 | 12/04/2024 | 22/04/2024 | 03/06/2024 | 10/06/2024 | 14/06/2024 | 21/06/2024 | 19/07/2024 |
02/04/2024 | 11/05/2024 | 21/05/2024 | 01/07/2024 | 08/07/2024 | 12/07/2024 | 19/07/2024 | 16/08/2024 |
27/05/2024 | 05/07/2024 | 15/07/2024 | 26/08/2024 | 02/09/2024 | 06/09/2024 | 13/09/2024 | 11/10/2024 |
15/07/2024 | 23/08/2024 | 02/09/2024 | 23/09/2024 | 30/09/2024 | 04/10/2024 | 11/10/2024 | 08/11/2024 |
12/08/2024 | 20/09/2024 | 30/09/2024 | 21/10/2024 | 28/10/2024 | 04/11/2024 | 08/11/2024 | 06/12/2024 |
16/08/2024 | 27/09/2024 | 07/10/2024 | 18/11/2024 | 25/11/2024 | 29/11/2024 | 06/12/2024 | 24/01/2025 |
04/11/2024 | 13/12/2024 | 23/12/2024 | 06/01/2025 | 13/01/2025 | 17/01/2025 | 24/01/2025 | 21/02/2025 |
02/12/2024 | 10/01/2025 | 20/01/2025 | 03/02/2025 | 10/02/2025 | 14/02/2025 | 21/02/2025 | 21/03/2025 |
*Provided that there is no need for written or oral explanation.