Europa Perspectives: Helping to Navigate the Regulatory System

Steffen Thirstrup, MD, PhD, chief medical officer, European Medicines Agency (EMA), was interviewed on Jan. 25, 2024 by Chris Spivey, editorial director of Pharmaceutical Technology® and BioPharm International® for the Europa Perspectives series. For the full interview transcript, click here.

This segment of discussion pivots around manufacturing supply, drug shortages, commercial incentives, politics, and, ultimately, patient wellbeing. A less well-understood role of the EMA is how the agency’s activities intersect with the factors driving pharmaceutical science forward. Thistrup outlines that, “We've done [much] in expanding our help into academia that are early in development, to small- and medium-size enterprises. We have an innovation task force where you can come and bounce off your idea and have a less formal conversation with us, how you could move those ideas into further development. [In addition], we still have our full-blown scientific advice procedure, which, coming back to the prices, we can do in conjunction with the health technology assessment bodies. So, independent of what happens on the patent side and data protection side, I think we are happy to help. That's our opportunity, and, fundamentally, the only role we have in driving innovation forward is to put our knowledge and our insight into drug development and the rules we are governing to the benefit of the developers, and try help them navigate the system.” He continues on to add, “So, engage early with us, and we don't bite. Sometimes regulators are seen as conservative and stubborn, but I think on the other, we are here to safeguard public health, but we are also here to help drive innovation forward, and especially drive innovation of potentially better products forward.”

Thirstrup is a medical doctor with a PhD in pharmacology and broad clinical experience in general internal medicine. He has a track record of working with the European Union regulatory network. He previously led the Division for Medicines Assessment and Clinical Trials at the Danish Health and Medicines Authority and was the Danish member of EMA’s human medicines committee (CHMP). He was also a member of EMA’s Committee for Advanced Therapies (CAT), the chairperson of the CHMP’s Respiratory Drafting Group and co-chair of the European Commission Working Group on Market Access of Biosimilars.