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EMA adopts open trial data policy

The European Medicines Agency (EMA) has decided to publish the clinical reports that underpin the decision-making on medicines. The new landmark policy will take effect 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.

“The adoption of this policy sets a new standard for transparency in public health and pharmaceutical research and development,” said Guido Rasi, EMA Executive Director. “This unprecedented level of access to clinical reports will benefit patients, healthcare professionals, academia and industry.”

EMA expects the new policy to increase trust in its regulatory work as it will allow the general public to better understand the Agency’s decision-making. In addition, academics and researchers will be able to re-assess data sets. The publication of clinical reports will also help to avoid duplication of clinical trials, foster innovation and encourage development of new medicines, states the EMA in a press release.

The policy will be implemented in phases with the first phase starting on 1 January 2015. Once a medicine has received a marketing authorisation, EMA will publish the clinical reports supporting applications for authorisation of medicines submitted after the policy’s entry into force.