EMA adopts landmark policy to take effect January 2015

In a bid toward greater transparency, the European Medicines Agency has decided to publish the clinical reports that underpin the decision-making on medicines.

Following extensive consultations held by the Agency with patients, health care professionals, academia, industry and other European entities over the past 18 months, the EMA management board unanimously adopted the new policy at its meeting yesterday. The policy will enter into force on January 1, 2015. It will apply to clinical reports contained in all applications for centralized marketing authorizations submitted after that date. The reports will be released as soon as a decision on the application has been taken.

Sets a new standard for transparency