The Regulation of Advanced Therapies: Perspectives from the EU

Lawyers Dr. Wolfgang Rehmann

The new regulation on advanced therapy products has closed a gap in the EU regulatory framework, but how will it serve the industry compared with the older system in the US?

Taylor Wessing partners, Wolfgang Rehmann and Gareth Morgan's article published in the Regulatory Affairs Journal compares and contrasts the regulatory frameworks in the US and the European Union for so-called “advanced therapies” that are being developed from human blood, cells, skin, bone and tissues. Such therapies are revolutionising the treatment of diseases and injuries, such as cancer, Parkinson’s disease, burns and cartilage injuries and regulating them is an important issue for governments.