European Medicines Agency publishes final advice from clinical trial advisory groups

The European Medicines Agency (EMA), on 30 April 2013, published the final advice from the advisory groups that were set up to inform the EMA in drafting its policy on proactive access to clinical-trial data.

The EMA has committed to the proactive publication of data from clinical trials supporting the authorisation of medicines once the marketing-authorisation process has ended, which the EMA does not consider commercially confidential.

The EMA will now draft a policy on proactive access to clinical-trial data. The final policy will be published at the end of November 2013 and the Agency expects the policy on proactive publication of clinical-trial data to come into force on 1 January 2014.