The pros and cons of the EC's Advanced Therapy Products proposal - an industry view
This article was originally published in Clinica
Executive Summary
The European Commission's proposal for a Regulation on Advanced Therapy Medicinal Products (ATPs) is a significant step towards EU-wide harmonisation and certainty for tissue engineered products. But this new clarity comes at a price to the medical devices industry. So say Voisin Consulting project director Dr Anne Dupraz Poiseau and fellow consultants Dr Stuart Mudge and Isabelle Mingam