Advanced Therapy Medicinal Products Regulation (EC) No 1394/2007 : How to make it work


Advanced Therapy Medicinal Products Regulation (EC) No 1394/2007 : How to make it work

Purpose of this meeting

To brief MEPs and Permanent Representatives on the concerns of the biotechnology industry on Member State application of the Regulation on Advanced therapy medicinal products.


Advanced therapies offer the ability to treat diseases in new ways, and the future possibility to cure, rather than merely treat, some diseases. With the Advanced Therapies Regulation, which will apply from 30 December 2008, there is a regulatory framework for industry to put their products on the market in all Member States at the same time. The Regulation creates a single European marketing authorisation for the next generation of cell-therapy, gene-therapy and tissue engineered products.This will allow these products to be placed on the European market only after rigorous review and approval by the EMEA. However the Regulation only will ensure consistency and the efficiency if Member States apply the Regulation in a consistent manner, support the EMEA’s competences to meet these demands and communicate about the new rules.