Certification procedures for advanced therapies under development by 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:

Procedural advice on the certification of quality and non-clinical data for small and medium-sized enterprises developing advanced therapy medicinal products

AdoptedReference Number: EMEA/CAT/418458/2008/corr.

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

Reference Number: EMA/CAT/45460/2010

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:

Guideline on the minimum quality and non-clinical data for certification of advanced therapy medicinal products

AdoptedReference Number: EMEA/CAT/486831/2008/corr.

Overview of comments received on draft scientific guideline on the minimum quality and non-clinical data for certification of advanced therapy medicinal products

Reference Number: EMA/CAT/45852/2010

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:

• Pre-submission request form

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:

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 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'.

For fees payable for ATMP consultation, please see:

• Fees payable to the European Medicines Agency

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*
02/01/2025	10/02/2025	20/02/2025	31/03/2025	07/04/2025	09/04/2025	16/04/2025	16/05/2025
03/02/2025	14/03/2025	24/03/2025	28/04/2025	05/05/2025	09/05/2025	16/05/2025	13/06/2025
24/02/2025	04/04/2025	14/04/2025	26/05/2025	02/06/2025	06/06/2025	13/06/2025	18/07/2025
31/03/2025	08/05/2025	19/05/2025	30/06/2025	07/07/2025	11/07/2025	18/07/2025	14/08/2025
26/05/2025	04/07/2025	14/07/2025	25/08/2025	01/09/2025	05/09/2025	12/09/2025	10/10/2025
14/07/2025	22/08/2025	01/09/2025	22/09/2025	29/09/2025	03/10/2025	10/10/2025	07/11/2025
11/08/2025	19/09/2025	29/09/2025	20/10/2025	27/10/2025	31/10/2025	07/11/2025	05/12/2025
18/08/2025	26/09/2025	06/10/2025	17/11/2025	24/11/2025	28/11/2025	05/12/2025	23/01/2026
06/10/2025	14/11/2025	24/11/2025	05/01/2026	12/01/2026	16/01/2026	23/01/2026	20/02/2026
03/11/2025	12/12/2025	22/12/2025	02/02/2026	09/02/2026	13/02/2026	20/02/2026	20/03/2026
08/12/2025	16/01/2026	26/01/2026	02/03/2026	09/03/2026	13/03/2026	20/03/2026	17/04/2026
05/01/2026	13/02/2026	23/02/2026	30/03/2026	07/04/2026	10/04/2026	17/04/2026	13/05/2026
26/01/2026	06/03/2026	16/03/2026	28/04/2026	04/05/2026	06/05/2026	13/05/2026	19/06/2026
02/03/2026	10/04/2026	20/04/2026	01/06/2026	08/06/2026	12/06/2026	19/06/2026	17/07/2026
30/03/2026	08/05/2026	18/05/2026	29/06/2026	06/07/2026	10/07/2026	17/07/2026	14/08/2026
22/05/2026	03/07/2026	13/07/2026	24/08/2026	31/08/2026	04/09/2026	11/09/2026	09/10/2026

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