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European Medicines Agency pledges to publish clinical reports

BMJ 2014; 349 doi: http://dx.doi.org/10.1136/bmj.g6086 (Published 07 October 2014) Cite this as: BMJ 2014;349:g6086
  1. Rory Watson
  1. 1Brussels

The European Medicines Agency, after widespread pressure from scientists and the public, will soon publish the clinical reports that underpin market authorisation requests for new drugs.

The decision, taken unanimously by the agency’s management board on 2 October, is part of its more proactive policy on transparency. It will apply to all centralised marketing authorisations submitted after 1 January 2015.

Announcing the commitment, Guido Rasi, the agency’s executive director, said, “The adoption of this policy sets a new standard for transparency in public health and pharmaceutical research and development. This unprecedented level of access to clinical reports will benefit patients, healthcare professionals, academia, and industry.”

The policy overturns the agency’s previous insistence that clinical data would be made available through a read only format that could …

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