Brussels, 19/05/2005 (Agence Europe) - On 19 May, one year after the definitive adoption of the directive setting quality and safety standards for human cells and tissues, the European Commission presented the new authorisation procedure for the sales of products created from cell and tissue engineering, which are increasingly used in medicine, to repair physical damage or as a medical treatment. This new centralised procedure will be managed in London by the European Medicines Agency.
Tissue engineering combines various aspects of medicine, cellular and molecular biology, materials science and engineering, for the purpose of regenerating, repairing or replacing diseased tissues. The treatment of diseases or injuries of the skin, cartilage and bones is one of the current applications of this new field of regenerative medicine. More complex products- such as heart valves or blood vessels- are already being prepared. The lack of any classification and authorisation procedure harmonised at EU level has led to differences of opinion between the approaches of the Member States, which has the effect of hampering the free movement of human tissue engineering products and of blocking patients' access to these innovative therapies. For this reason, the European Commission has undertaken to draw up a clear regulatory framework. Before presenting an official proposal, which it will do in the course of this year, it has called upon the public to voice observations on a draft regulatory framework on the authorisation, supervision and post-authorisation vigilance of advanced therapies: tissue engineering, cell therapy and genetic therapy.
The main elements of the draft are as follows: 1) a centralised marketing authorisation procedure, to benefit from the pool of expertise at European level and direct access to the EU market; 2) a new multidisciplinary expert committee (Committee for Advanced Therapies) within the European Medicines Agency (EMA), in charge of assessing advanced therapy products and following scientific developments in this field; 3) tailored technical requirements adapted to the particular scientific characteristics of the products; 4) detailed guidance for the application of good manufacturing practice and good clinical practice to advanced therapies; 5) strengthened requirements for risk management and post-authorisation traceability; 6) a system of low-cost, stop quality scientific advice for the industry, provided by the European Medicines Agency; 7) financial and administrative incentives for small and medium-sized enterprises developing advanced therapies.
The regulation must respect the Charter of Fundamental Rights of the EU and the Convention on biomedicine of the Council of Europe. Decisions concerning the use or non-use of a specific type of human cell, such as germ cells or embryonic stem cells, are entirely under the jurisdiction of the Member States. Products obtained from human cells and tissues will continue to be governed by the principles of voluntary unpaid donation, donor and recipient anonymity, donor altruism and solidarity between donor and recipient.
All interested parties are called upon to voice their observations by 20 June 2005, by sending them to the following address: http: //pharmacos.eudra.org/F2/advtherapies/index.htm.