About the Authors

Hans-Georg Eichler, Eric Abadie, Hubert Leufkens, Guido Rasi
European Medicines Agency (EMA), London, United Kingdom

Eric Abadie
Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) Saint-Denis, France

Alasdair Breckenridge
Medicines and Healthcare products Regulatory Agency (MHRA), London, United Kingdom

Hubert Leufkens
Medicines Evaluation Board (CBG-MEB), Den Haag, The Netherlands

Corresponding Author


Competing Interests

All authors work for drug regulatory agencies. The authors have declared that no other competing interests exist. The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agencies, or the committees or working parties of the regulatory agencies the authors work for.

Author Contributions

Wrote the first draft of the manuscript: HGE. Contributed to the writing of the manuscript: HGE EA AB HL GR. ICMJE criteria for authorship read and met: HGE EA AB HL GR. Agree with manuscript results and conclusions: HGE EA AB HL GR.