European drug regulators publish their evaluation of rosiglitazone

BMJ 2010; 341 doi: (Published 17 December 2010) Cite this as: BMJ 2010;341:c7278
  1. Susan Mayor
  1. 1London

European drug regulators have for the first time published full details of their evaluation of rosiglitazone that led to the recommendation for it to be withdrawn.

In what they describe as a major step to improve the transparency of drug regulation the European Medicines Agency (EMA), the Swedish Medical Products Agency (Läkemedelsverket), the Dutch Medicines Evaluation Board, and the Agence Française de Sécurité Sanitaire des Produits de Santé have published an article in the journal of the European Association for the Study of Diabetes, Diabetologia, that maps the life cycle of their deliberations on rosiglitazone (doi:10.1007/s00125-010-1992-5).

In a statement the regulatory bodies said, “This paper opens a new area of improved communication between health authorities and the academic world, providing an insight into the processes and decision-making concerning drugs in Europe.”

One of the authors, Eberhard Blind, head of endocrinology, metabolism, cardiovascular safety, and efficacy of medicines with the EMA in London, said, “The intention of the authors of publishing additionally in a scientific journal …

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