Updated 28/10/2025:
Added 2026 dates for submission of ATMP-classification requests
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:
To submit an application for ATMP classification, complete:
Return both forms to atmpclassification@ema.europa.eu
Information on the ATMP classification procedure is available below:
In June 2015, EMA published the adopted revised reflection paper on the classification of ATMPs.
For previous versions, see:
| Deadline for request for ATMP classification | Start of procedure | CAT discussion | CAT adoption |
|---|---|---|---|
| Day -15 | Day 0 | Day 30 | Day 60 |
| 9 Jan 2025 | 24 Jan 2025 | 21 Feb 2025 | 21 Mar 2025 |
| 6 Feb 2025 | 21 Feb 2025 | 21 Mar 2025 | 16 Apr 2025 |
| 6 Mar 2025 | 21 Mar 2025 | 16 Apr 2025 | 16 May 2025 |
| 1 Apr 2025 | 16 Apr 2025 | 16 May 2025 | 13 Jun 2025 |
| 30 Apr 2025 | 19 May 2025 | 13 Jun 2025 | 18 Jul 2025 |
| 29 May 2025 | 16 Jun 2025 | 18 Jul 2025 | 14 Aug 2025 |
| n/a | n/a | n/a | n/a |
| 30 Jul 2025 | 14 Aug 2025 | 12 Sep 2025 | 10 Oct 2025 |
| 28 Aug 2025 | 12 Sep 2025 | 10 Oct 2025 | 07 Nov 2025 |
| 25 Sep 2025 | 10 Oct 2025 | 07 Nov 2025 | 05 Dec 2025 |
| 23 Oct 2025 | 24 Nov 2025 | 05 Dec 2025 | 23 Jan 2025 |
| 20 Nov 2025 | 22 Dec 2025 | 23 Jan 2026 | 20 Feb 2025 |
| Deadline for request for ATMP classification |
Start of procedure | CAT discussion | CAT adoption |
|---|---|---|---|
| Day -15 | Day 0 | Day 30 | Day 60 |
| 8 Jan 2026 | 23 Jan 2026 | 20 Feb 2026 | 20 Mar 2026 |
| 5 Feb 2026 | 20 Feb 2026 | 20 Mar 2026 | 17 Apr 2026 |
| 5 Mar 2026 | 20 Mar 2026 | 17 Apr 2026 | 13 May 2026 |
| 2 Apr 2026 | 20 Apr 2026 | 13 May 2026 | 19 Jun 2026 |
| 30 Apr 2026 | 18 May 2026 | 19 Jun 2026 | 17 Jul 2026 |
| 4 Jun 2026 | 19 Jun 2026 | 17 Jul 2026 | 14 Aug 2026 |
| n/a | n/a | n/a | n/a |
| 30 Jul 2026 | 14 Aug 2026 | 11 Sep 2026 | 9 Oct 2026 |
| 27 Aug 2026 | 11 Sep 2026 | 9 Oct 2026 | 6 Nov 2026 |
| 24 Sep 2026 | 9 Oct 2026 | 6 Nov 2026 | 4 Dec 2026 |
| 22 Oct 2026 | 23 Nov 2026 | 4 Dec 2026 | 22 Jan 2027 |
| 19 Nov 2026 | 21 Dec 2026 | 22 Jan 2027 | 19 Feb 2027 |