Commission seeks stakeholder views on human tissue engineering
The European Commission has prepared a consultation document on proposed legislation designed to harmonise rules on the authorisation of human tissue engineered products. At present, there is no uniform and comprehensive regulatory framework in the Community covering human tissue engineered products. The European Commission therefore announced in its action plan for 2004 that it would propose legislation harmonising the rules on the authorisation of such products. The public consultation invites stakeholders to present their views on key aspects of the future proposal. For this purpose, the Commission's DG Enterprise prepared a consultation document suggesting the key issues to be addressed in future legislation, as well as the structure and main requirements of the authorisation procedure. Primarily, the Commission invites contributions from: business associations at the European, national or regional level; enterprises; public administrations; patient and health associations; other organisations active or interested in the field of tissue engineering; hospitals; tissue banks; medical specialists; researchers; academics and other experts; and actors in the field of social and health insurance.