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 applicationSubmission of final applicationStart of procedureCoordinator's evaluation reportComments for CAT members and peer reviewersConsolidated evaluation reportDiscussion at CAT (day 60)CAT adoption of opinion*
13/07/201821/08/201831/08/201824/09/201801/10/201805/10/201812/10/201809/11/2018
10/08/201818/09/201828/09/201822/10/201829/10/201805/11/201809/11/201807/12/2018
20/08/201828/09/201808/10/201819/11/201826/11/201830/11/201807/12/201825/01/2019
08/10/201816/11/201826/11/201807/01/201914/01/201918/01/201925/01/201922/02/2019
31/10/201811/12/201921/12/201804/02/201911/02/201915/02/201922/02/201922/03/2019
10/12/201818/01/201928/01/201904/03/201911/03/201915/03/201922/03/201917/04/2019
21/12/201805/02/201915/02/201901/04/201908/04/201912/04/201917/04/201924/05/2019
04/02/201915/03/201925/03/201906/05/201913/05/201917/05/201924/05/201921/06/2019
27/02/201905/04/201917/04/201903/06/201910/06/201914/06/201921/06/201919/07/2019
01/04/201910/05/201920/05/201901/07/201908/07/201912/07/201919/07/201916/08/2019
27/05/201905/07/201915/07/201926/08/201902/09/201906/09/201913/09/201911/10/2019
12/07/201920/08/201930/08/201923/09/201930/09/201904/10/201911/10/201908/11/2019
09/08/201917/09/201927/09/201921/10/201928/10/201931/10/201908/11/201906/12/2019
19/08/201927/09/201907/10/201918/11/201925/11/201929/11/201906/12/201924/01/2020
11/10/201919/11/201929/11/201906/01/202013/01/202017/01/202024/01/202021/02/2020
04/11/201913/12/201923/12/201903/02/202010/02/202014/02/202021/02/202020/03/2020
02/12/201910/01/202020/01/202002/03/202009/03/202013/03/202020/03/202024/04/2020
06/01/202014/02/202024/02/202006/04/202014/04/202017/04/202024/04/202020/05/2020
30/01/201910/03/201920/03/201904/05/202011/05/202015/05/202020/05/202019/06/2020
02/03/202010/04/202020/04/202002/06/202008/06/202012/06/202019/06/202017/07/2020
30/03/202008/05/202018/05/202029/06/202006/07/202010/07/202017/07/202014/08/2020
25/05/202003/07/202013/07/202024/08/202031/08/202004/09/202011/09/202009/10/2020

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

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