About the Authors

Hans-Georg Eichler

hans-georg.eichler@ema.europa.eu

Affiliation European Medicines Agency (EMA), London, United Kingdom

Eric Abadie

Affiliations European Medicines Agency (EMA), London, United Kingdom, Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) Saint-Denis, France

Alasdair Breckenridge

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

Hubert Leufkens

Affiliations European Medicines Agency (EMA), London, United Kingdom, Medicines Evaluation Board (CBG-MEB), Den Haag, The Netherlands

Guido Rasi

Affiliation European Medicines Agency (EMA), London, United Kingdom

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.