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').

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 SMEs developing ATMPs
• Overview of comments received on procedural advice on the certification of quality and non-clinical data for SMEs developing ATMPs

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 ATMPs
• Overview of comments received on draft scientific guideline on the minimum quality and non-clinical data for certification of ATMPs

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:

• Presubmission request form: intent to submit

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:

• Pre-submission request form: ATMP certification
• List of annexes

After validation, re-submit the ATMP certification dossier via Eudralink to the CAT members and via EMA service desk.

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