Advanced-therapy medicinal product classification

Applicants have access to an optional procedure to determine whether medicines based on genes, cells or tissues meet the scientific criteria that define advanced-therapy medicinal products (ATMPs), according to article 17 of Regulation (EC) No 1394/2007 on ATMPs.

This procedure has been established by the legislator with a view to addressing, as early as possible, questions of borderline classification with other areas such medical devices.

The European Medicines Agency'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.

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 advancedtherapies@ema.europa.eu.

Dates for submission of the request for ATMP classification in 2011-2012

*Expected dates for adoption if the CAT requires no additional information is required to conclude on the classification (no clock stop during the procedure).

Scientific recommendations

• Summaries of scientific recommendations

Procedural advice

Information on the ATMP classification procedure is available in:

• 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 April 2012, the Agency released a reflection paper on ATMP classification for a three-month public consultation:

• Reflection paper on classification of ATMPs