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The European Medicines Agency has published its letter of reply to the Ombudsman’s concerns about changes in transparency – see my previous blog. The letter makes the point that the new transparency policy is an initiative of the agency itself and is quite distinct from the access to documents regime under Directive 1049/2001, and also… » read more

Posted by Jim Murray

There has been an apparent volte-face by the European Medicines Agency on its earlier promise of a pro-active transparency policy that was about “establishing trust and confidence and enabling independent re-analysis of the evidence used by the EMA scientific committees to determine the benefits and risks of medicines “ See here for a critique of… » read more

Posted by Jim Murray