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Medicines agency rejects a quarter of requests for documents it holds on drugs

BMJ 2012; 345 doi: (Published 27 December 2012) Cite this as: BMJ 2012;345:e8684
  1. Ingrid Torjesen
  1. 1London

The European Medicines Agency (EMA) has released more than 1.6 million pages of documents that it previously treated as confidential, but rejected a quarter of requests in the first two years of its policy to grant access to documents on request.

Since 30 November 2010, researchers, commercial companies, and the general public have been able to request access to “any document originated, received or held by the agency” including clinical study reports, assessment reports, periodic safety update reports, and clinical data submitted by companies seeking marketing authorisation for their products.

In the first two years of this policy the EMA received 455 requests for information—178 in the first year and 277 in the …

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