Certification procedures for micro-, small- and medium-sized enterprises (SMEs)

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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 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*

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

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