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:

• Summaries of scientific recommendations

Applying for ATMP classification

To submit an application for ATMP classification, complete:

• ATMP classification - administrative information sheet
• Scientific recommendation on classification of advanced therapy medicinal products: Request form and briefing information Article 17 - Regulation (EC) No 1394/2007

Return both forms to [e-mail]

Procedural advice on ATMP classification

Information on the ATMP classification procedure is available below:

• Procedural advice on the provision of scientific recommendation on classification of advanced therapy medicinal products in accordance with Article 17 of Regulation (EC) No 1394/2007
• Draft procedural advice on the provision of scientific recommendation of classification of advanced therapy medicinal products in accordance with article 17 of regulation (EC) NO 1394/2007
• Overview of comments received on 'Procedural Advice on the Provision of Scientific Recommendation on Classification of Advanced Therapy Medicinal Products in Accordance with Article 17 of Regulation (EC) No. 1394/2007'

Reflection paper on ATMP classification

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

• Reflection paper on classification of advanced therapy medicinal products
• Overview of comments received on 'Reflection paper on classification of advanced therapy medicinal products'

For previous versions, see:

• Draft reflection paper on classification of advanced-therapy medicinal products

  (30/06/2014)

• Reflection paper on classification of advanced-therapy medicinal products

  (17/12/2012)

• Reflection paper on classification of advanced-therapy medicinal products

   (30/04/2012)

Dates for submission of ATMP-classification requests: 2026

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