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High-Profile EU Regulators Join Forces In Consultancy Partnership

Executive Summary

Tomas Salmonson and Rob Hemmings will provide consultancy services to the industry they regulated for a combined 50 years.

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PROFILE: Tomas Salmonson, chair of the EMA's CHMP, on European collaboration, being a teenage lifeguard, and Persian rugs

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is the body that effectively says yes or no to your new drug in Europe. Since September 2012, the committee has been chaired by senior Swedish regulator Tomas Salmonson. In this profile, by Francesca Bruce, find out what Dr Salmonson thinks of the pharmaceutical industry and what key advice he would give companies looking for regulatory approval… and also how he relaxes, what shaped him growing up and why he thinks his grandfather would be proud of him.

EU Accelerated Assessment Tracker

Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.

EU Accelerated Assessment Tracker

The EU filing for AstraZeneca’s nirsevimab is being reviewed under the accelerated pathway at the European Medicines Agency. Also, Janssen should know by now whether its planned filing for Zejula plus Zytiga will get the same treatment – as should SIFI for its planned Akantior filing.

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