European Medicines Agency responds to criticism over transparency in British Medical Journal

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23/05/2011

European Medicines Agency responds to criticism over transparency in British Medical Journal

The European Medicines Agency has responded to an article published in the British Medical Journal (BMJ) that called for more transparency by medicines regulatory authorities.

The letter, which was published on the BMJ's website on Friday 13 May, outlines the steps that the Agency has taken to increase its transparency since its establishment in 1995.

These steps include the new access to documents policy, which came into effect in November 2010 and the launch of the European Union Clinical Trials Register. The Agency has also launched public consultations on the draft policy concerning the release of safety data held in the EudraVigilance database and on the draft transparency policy.

The letter, signed by the Agency's acting Executive Director, responded to the article 'Opening up data at the European Medicines Agency' by Peter Gøtzsche and Anders Jørgensen. The BMJ published this article online on Tuesday 10 May.

Related information

Contact point:

info@ema.europa.eu