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

Adopted Reference 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

Adopted Reference 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*
08/10/2026	16/11/2026	26/11/2026	04/01/2027	11/01/2027	15/01/2027	22/01/2027	19/02/2027
02/11/2026	11/12/2026	21/12/2026	01/02/2027	08/02/2027	12/02/2027	19/02/2027	24/03/2027
07/12/2026	15/01/2027	25/01/2027	08/03/2027	15/03/2027	17/03/2027	24/03/2027	23/04/2027
04/01/2027	12/02/2027	22/02/2027	05/04/2027	12/04/2027	16/04/2027	23/04/2027	21/05/2027
01/02/2027	12/03/2027	22/03/2027	03/05/2027	10/05/2027	14/05/2027	21/05/2027	18/06/2027
01/03/2027	09/04/2027	19/04/2027	31/05/2027	07/06/2027	11/06/2027	18/06/2027	16/07/2027
30/03/2027	05/05/2027	18/05/2027	28/06/2027	05/07/2027	09/07/2027	16/07/2027	13/08/2027
31/05/2027	09/07/2027	19/07/2027	23/08/2027	30/08/2027	03/09/2027	10/09/2027	08/10/2027
05/07/2027	13/08/2027	23/08/2027	20/09/2027	27/09/2027	01/10/2027	08/10/2027	05/11/2027
02/08/2027	10/09/2027	20/09/2027	18/10/2027	25/10/2027	29/10/2027	05/11/2027	10/12/2027
23/08/2027	01/10/2027	11/10/2027	22/11/2027	29/11/2027	03/12/2027	10/12/2027	21/01/2028
04/10/2027	12/11/2027	22/11/2027	03/01/2028	10/01/2028	14/01/2028	21/01/2028	18/02/2028
29/10/2027	10/12/2027	20/12/2027	31/01/2028	07/02/2028	11/02/2028	18/02/2028	17/03/2028
06/12/2027	14/01/2028	24/01/2028	28/02/2028	06/03/2028	10/03/2028	17/03/2028	12/04/2028
03/01/2028	07/02/2028	17/02/2028	27/03/2028	03/04/2028	05/04/2028	12/04/2028	12/05/2028
24/01/2028	03/03/2028	13/03/2028	24/04/2028	02/05/2028	05/05/2028	12/05/2028	16/06/2028
29/02/2028	07/04/2028	18/04/2028	29/05/2028	06/06/2028	09/06/2028	16/06/2028	14/07/2028
27/03/2028	05/05/2028	15/05/2028	26/06/2028	03/07/2028	07/07/2028	14/07/2028	11/08/2028

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

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in September 2026.

See update history

29 September 2026

Submission deadlines updated