Letters Access to clinical trial data

Is the EMA’s window of opportunity as widely open as described?

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g1411 (Published 12 February 2014) Cite this as: BMJ 2014;348:g1411
  1. Bruno Toussaint, publishing director1
  1. 1Prescrire, 75558 Paris Cedex 11, France
  1. contact{at}prescrire.org

Doshi and Groves recommend that readers get the data they might need from the European Medicines Agency (EMA) while they can, in light of potential changes to its policy on access to documents.1 The agency’s transparency requirements are enshrined in the EU directive 200/83/EC, which regulates drug products, and in the European freedom of information regulation (1049/2001).

At Prescrire, an independent drug bulletin, we have conducted …

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