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:
- pre-submission request form (select 'ATMP-ATMP classification' in the drop-down menu);
- 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
- 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)
Dates for submission of ATMP-classification requests: 2016
|Deadline for submission of request||Start of procedure||Recommendation adopted by CAT pending receipt of comments from the European Commission (EC)*||Adoption in case of major comments received from EC|
|Day -15||Day 0||Day 30||Day 60|
*Expected dates for adoption if the CAT requires no additional information to conclude on the classification (with no clock stop during the procedure).
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- 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 (19/12/2013)
- Reflection paper on classification of advanced therapy medicinal products (08/06/2015)
- Explanatory note on the presubmission request form (20/05/2014)