Opening up data at the European Medicines Agency.

نویسندگان

Peter C Gøtzsche

Anders W Jørgensen

چکیده

The European Medicines Agency has taken important steps towards increasing its transparency over recent years. Mr Gotzsche and Mr Jorgensen themselves have acknowledged that the Agency's new access to documents policy which became effective in November 2010 has pushed transparency further forward than in most other drug regulatory authorities. The current policy grants wider access than ever before to documents originated, received or held by the Agency. This includes clinical trials reports submitted to the Agency as part of a marketing authorisation application. The extended access to documents and reactive disclosure of documents will be complemented by an extended proactive publication of these documents over the next years.

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