EMA adopts landmark policy

EMA adopts landmark policy to take effect on 1 January 2015

EMA has decided to publish the clinical reports that underpin the decision-making on medicines. EMA Management Board unanimously adopted the new policy at its meeting on 2 October 2014. The policy will enter into force on 1 January 2015. It will apply to clinical reports contained in all applications for centralised marketing authorisations submitted after that date. The reports will be released as soon as a decision on the application has been taken.

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