Tissue engineering and beyond: Consultation on a proposal for a Regulation on advanced therapiesComments Off on Tissue engineering and beyond: Consultation on a proposal for a Regulation on advanced therapies

Before tabling a formal proposal later this year, the Commission is inviting the general public to comment on a draft regulatory framework for authorisation, supervision and post-authorisation vigilance of advanced therapies (tissue engineering, cell and gene therapy).

In the light of the first round of consultations, which took place earlier in 2002 and 2004 to which CPME answered (Policies – CPME 2002/116 final and CPME 2004/055), the principles and key elements of this legislative proposal have now been drafted and can be summarized as follows:

·         A centralised marketing authorisation procedure;

·         A multidisciplinary expert Committee within the European Medicines Agency (EMEA);

·         Tailored technical requirements;

·         guidance for good manufacturing and good clinical;

·         risk management and post-authorisation traceability;

·         low-cost advice by the European Medicines Agency;

·         incentives for small and medium-sized enterprises.

Ethical aspects regarding human tissues and cells are also taken into account

Comments on consultation paper and draft by all interested parties are welcome until 20 June 2005.