On the 12th of June 2014, the European Medicines Agency (EMA) Management Board agreed the policy on publication of clinical trial data, that will be effective from the 1st of October 2014.
It has been developed following the broadest possible consensus among its stakeholders and their often competing views and interests. After an extensive consultation phase that took place between June and September 2013, the Agency carried out a second round of targeted consultation in 2014.
The policy will allow the Agency to proactively publish clinical trial data that are submitted as part of marketing authorisation applications, giving the possibility to download, save and print trial data for academic and non-commercial research purposes. This is an important step forward towards achieving increased transparency in the regulation of medicines in Europe and it provides an unprecedented level of access to clinical trial data.
For more information, please visit the EMA website
