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New chair for Europe’s key medicines committee

Appointment comes amid Brexit-induced disruption and new era in medicines

The European Medicines Agency committee responsible for reviewing all innovative new medicines has a new chair, Germany’s Harald Enzmann.

The Committee for Medicinal Products for Human Use (CHMP) announced last Friday that it had elected Enzmann as its new chair, for a three-year term starting with immediate effect.

Dr Enzmann replaces Dr Tomas Salmonson, senior scientific advisor at the Swedish Medicinal Products Agency (MPA), who steps down after having served the maximum of two three-year terms as chairman.

Dr Enzmann trained as a medical doctor, before undertaking postdoctoral research in oncology, and working in pre-clinical research for Bayer before joining Germany’s medicines regulator the Federal Institute for Drugs and Medical Devices (BfArM) in 2005.

He currently serves as BfArM’s Head of European and International Affairs and has been a member of the CHMP, also since 2005, and its vice-chair since October 2016, making him the obvious choice to succeed Salmonson.

Harald Enzmann

Dr Harald Enzmann

Commenting on his appointment, Dr Enzmann said: “The CHMP is at the cutting edge of medical progress. With science evolving at such a fast pace, our challenge will be to achieve a balance between being agile to find solutions to emerging scientific or regulatory issues and being consistent with previous decisions.”

“As chair, I will try to elicit in a constructive way the committee members’ views, encourage their involvement and structure our scientific discussions to foster consensual decision-making.”

Like other major regulators, such as the US FDA, the EMA is updating its structures and review processes as new technologies such as gene and cell therapy emerge from industry pipelines. The CHMP has just recommended Luxturna, Spark's gene therapy, the product having first been reviewed by the EMA's new expert committee on Advanced Therapy Medicinal Products (ATMPs), the Committee for Advanced Therapies (CAT).

Relocation disruption

The new appointment coincides with one of the most difficult times in the agency’s history, as it is in the midst of a relocation from London to Amsterdam, due to Brexit.

The UK’s planned departure from the EU has added numerous additional workloads to the agency’s staff, including transfer of marketing authorisations from the UK to other EU member states, plus the upheaval of relocating to Amsterdam by April 2019.

Last month it announced that it expected to lose as much as 30% of its staff thanks to the move to Amsterdam.  Employment regulations in the Netherlands also mean that it will not be able to bring around 135 short-term contract employees with it in the move.

In order to protect the work of the CHMP and its supporting staff, the EMA say that by 1 October 2018, it will have scaled back non-core activities to ensure new drug reviews are not delayed.

The CHMP will elect a new vice-chair at its October 2018 meeting.

Article by
Andrew McConaghie

26th September 2018

From: Regulatory



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