Advanced therapy classification

Companies can consult the European Medicines Agency (EMA) to determine whether a medicine they are developing is an advanced therapy medicinal product (ATMP). The procedure allows them to receive confirmation that a medicine, which is based on genes, cells or tissues, meets the scientific criteria for defining an ATMP.

The criteria for ATMPs are set out in Article 17 of Regulation (EC) No 1394/2007. The classification procedure is optional.

EMA established the procedure to address questions on borderline classification with other areas, such as medical devices, as early as possible.

EMA's Committee for Advanced Therapies (CAT) delivers scientific recommendations on ATMP classification after consultation with the European Commission within 60 days after receipt of the request.

EMA publishes the outcome of the assessment of the classification of ATMPs as summary reports:

Applying for ATMP classification

To submit an application for ATMP classification, complete:

Return both forms to advancedtherapies@ema.europa.eu.

Procedural advice on ATMP classification

Information on the ATMP classification procedure is available below:

Reflection paper on ATMP classification

In June 2015, EMA published the adopted revised reflection paper on the classification of ATMPs.

For previous versions, see:

Dates for submission of ATMP-classification requests: 2019

Dates for submission of ATMP-classification requests: 2020

Deadline for request for ATMP classification

Start of the procedure

*Recommendation adopted by CAT pending receipt of comments from EC

Adoption in case of major comments received from EC

Day -15

Day 0

Day 30

Day 60

09-Jan-20

24-Jan-20

21-Feb-20

20-Mar-20

06-Feb-20

24-Feb-20

20-Mar-20

24-Apr-20

05-Mar-20

23-Mar-20

24-Apr-20

20-May-20

08-Apr-20

24-Apr-20

20-May-20

19-Jun-20

05-May-20

20-May-20

19-Jun-20

17-Jul-20

04-Jun-20

19-Jun-20

17-Jul-20

14-Aug-20

N/A

N/A

N/A

N/A

30-Jul-20

14-Aug-20

11-Sep-20

09-Oct-20

27-Aug-20

11-Sep-20

09-Oct-20

06-Nov-20

24-Sep-20

09-Oct-20

06-Nov-20

04-Dec-20

22-Oct-20

23-Nov-20

04-Dec-20

22-Jan-21

19-Nov-20

21-Dec-20

22-Jan-21

19-Feb-21

 

*Expected dates for adoption in case that no additional information is required by the CAT to conclude on the classification (no clock-stop during the procedure) .

Dates for submission of ATMP-classification requests: 2019

Deadline for requestStart of the procedure*Recommendation adopted by CAT pending receipt of comments from ECAdoption in case of major comments received from EC
Day -15Day 0Day 30Day 60
10/01/201925/01/201922/02/201922/03/2019
07/02/201922/02/201922/03/201917/04/2019
07/03/201925/03/201917/04/201924/05/2019
02/04/201923/04/201924/05/201921/06/2019
08/05/201924/05/201921/06/201919/07/2019
06/06/201921/06/201919/07/201916/08/2019
N/AN/AN/AN/A
01/08/201916/08/201913/09/201911/10/2019
29/08/201913/09/201911/10/201908/11/2019
26/09/201911/10/201908/11/201906/12/2019
24/10/201925/11/201906/12/201924/01/2020
21/11/201923/12/201924/01/202021/02/2020

*Expected dates for adoption in case that no additional information is required by the CAT to conclude on the classification (no clock-stop during the procedure).

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