Advanced Therapies
This article was originally published in SRA
Executive Summary
Work on proposal continues
Work on proposal continues
The European Commission is working on an impact assessment detailing how comments on its recent proposed framework for the regulation of advanced therapies have been taken into account1. The proposal, which was released on 4 May 2005, puts forward an approach to establish a single regulatory mechanism for all advanced therapy products, including human tissue-engineered products, within the EU. Comments received will be published on the commission website shortly. The proposal is part of the Commission Legislative and Work Programme for 2005 and is on track to be formally adopted by the commission and officially published in November 2005. It will then be forwarded to the council and European parliament.
References
1. Personal communication, European Commission, 26 September 2005