EU Legislative Review Needs To ‘Fix The Ecosystem’ For ATMPs

Developers of advanced therapies say the European Commission must do more to address the “hospital exemption” and the regulation of advanced therapy medicinal products as genetically modified organisms.

New genetic engineering platforms — Industry has a wishlist for the regulation of ATMPs in the EU • Source: Shutterstock

The upcoming revision of the EU pharmaceutical legislation is a “once-in-a-generation opportunity” to make sure that Europe is planning for the future of medicine, as opposed to continuing the policies of the past that were designed for “traditional pharmaceuticals,” according to Stephen Majors, senior director of public affairs at the Alliance for Regenerative Medicine.

ARM’s data show that the number of clinical trials of ATMPs (advanced therapy medicinal products) is stagnating in Europe, as...