Experience with the ATMP Regulation (Report)

The Commission indicates that it is generally satisfied with the application of the Regulation on advanced therapy medicinal products (ATMP Regulation) but considers that it could be improved by extending the certification procedure to include universities and other non-commercial institutions. In addition, it calls for restriction of the hospital exemption, which allows ATMPs to be used without a marketing authorisation in domestic hospitals.

cepPolicyBrief

Extending the certification procedure to include universities and other non-commercial institutions gives these institutions better access to external finance. This is necessary in order for them to convert their ATMPs into marketable products. On the other hand, revision of the hospital exemption is unnecessary because, contrary to the Commission's belief, it will not provide an incentive for applying for the EU-wide authorisation of ATMPs.

Download PDF

Experience with the ATMP Regulation COM(2014) 188 (publ. 09.09.2014)	PDF	98 KB	Download