EU Invites Public Comment on Tissue Engineering Regulation

"A new biotechnology area has emerged: human tissue engineering, which combines various aspects of medicine, cell and molecular biology, materials science and engineering, for the purpose of regenerating, repairing or replacing diseased tissues. Current applications of this nascent field of 'regenerative medicine' include treatment for skin, cartilage and bone diseases or injuries.

More complex products - such as heart valves or blood vessels - are already in the pipeline. Tissue engineered products currently lie outside any legislative framework.

This is why the European Commission is working on a clear regulatory framework. Before tabling a formal proposal later this year, the Commission has now invited 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). This consultation is part of the impact assessment of the upcoming proposal. "

Read more in this Medical News Today article.