How to commercialise ATMPs in the EU

NDA’s Paula Salmikangas, Director for Biopharmaceuticals and ATMPS, NDA Advisory Board and Steffen Thirstrup, Director NDA Advisory Board, have co-authored the article ‘How to commercialise ATMPs in the EU’.


Cell and gene therapy medicinal products, together with tissue engineering products (so-called advanced therapy medicinal products, ATMPs) are under active research globally. In the EU the legal and regulatory framework
has been in place for a decade.

However, the speed of scientific progress is challenging the available guidance and existing rulesets for ATMPs. This discrepancy has been noted by the European Commission (EC) and the European Medicines Agency (EMA), which, together, released an action plan for ATMPs in December 2017.

This article addresses recent findings from the EMA PRIME scheme and provides information about procedural updates and evolving guidance in the ATMP area.

The article is also featured in Regulatory Rapporteur – Vol 15, No 7/8, July/August 2018. Regulatory Rapporteur is TOPRAs respected, peer-reviewed journal and it is published 11 times per year and is free to TOPRA members.