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 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:
- ATMP classification – administrative information ;
- ATMP-classification request form and briefing information (including background information on scientific, legal, regulatory and medical aspects).
Return both forms to email@example.com.
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 ATMPs in accordance with Article 17 of Regulation (EC) No 1394/2007 (under revision - November 2020)
- 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 ATMPs in accordance with Article 17 of Regulation (EC) No. 1394/2007' (EMA/CAT/99623/2009)
Reflection paper on ATMP classification
In June 2015, EMA published the adopted revised reflection paper on the classification of ATMPs.
- Adopted reflection paper on classification of ATMPs Rev.1 (08/06/2015)
- Overview of comments received on 'Reflection paper on classification of advanced therapy medicinal products' (17/06/2015)
For previous versions, see:
- Draft reflection paper on classification of ATMPs Rev.1 (30/06/2014)
- Adopted reflection paper on classification of ATMPs (17/12/2012)
- Draft reflection paper on classification of ATMPs (30/04/2012)
|Deadline for request for ATMP classification||Start of procedure||CAT discussion||CAT adoption|
|Day -15||Day 0||Day 30||Day 60|