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 on the certification

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

Guideline on the minimum quality and non-clinical data for certification of ATMPs

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

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 form below and return it to pa-bus@ema.europa.eu together with the annexes and application dossier for certification:

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*
02/06/201411/07/201421/07/201401/09/201408/09/201412/09/201419/09/201417/10/2014
08/07/201415/08/201426/08/201429/09/201406/10/201410/10/201417/10/201414/11/2014
04/08/201412/09/201422/09/201427/10/201403/11/201407/11/201414/11/201412/12/2014
01/09/201410/10/201420/10/201424/11/201401/12/201405/12/201412/12/201416/01/2015
06/10/201414/11/201424/11/201405/01/201509/01/201512/01/201516/01/201520/02/2015
03/11/201412/12/201422/12/201402/02/201509/02/201513/02/201520/02/201520/03/2015
08/12/201416/01/201526/01/201502/03/201509/03/201513/03/201520/03/201517/04/2015
05/01/201513/02/201523/02/201530/03/201507/04/201510/04/201517/04/201513/05/2015
02/02/201513/03/201523/03/201527/04/201504/05/201507/05/201513/05/201519/06/2015
09/03/201517/04/201527/04/201501/06/201508/06/201512/06/201519/06/201517/07/2015
07/04/201513/05/201526/05/201529/06/201506/07/201510/07/201517/07/201514/08/2015
01/06/201510/07/201520/07/201501/09/201507/09/201511/09/201518/09/201516/10/2015
14/07/201521/08/201501/09/201528/09/201505/10/201509/10/201516/10/201513/11/2015
10/08/201518/09/201528/09/201526/10/201503/11/201506/11/201513/11/201511/12/2015
07/09/201516/10/201526/10/201523/11/201530/11/201504/12/201511/12/201522/01/2016
08/10/201516/11/201526/11/201504/01/201611/01/201615/01/201622/01/201619/02/2016
16/11/201523/12/201504/01/201601/02/201608/02/201612/02/201619/02/201623/03/2016
07/12/201515/01/201625/01/201607/03/201614/03/201616/03/201623/03/201622/04/2016
04/01/201612/02/201622/02/201604/04/201611/04/201615/04/201622/04/201620/05/2016
01/02/201611/03/201621/03/201602/05/201610/05/201613/05/201620/05/201617/06/2016
29/02/201608/04/201618/04/201630/05/201606/06/201610/06/201617/06/201615/07/2016
29/03/201604/05/201617/05/201627/06/201604/07/201608/07/201615/07/201612/08/2016

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

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