Release of data from clinical trials

European Medicines Agency: 11/22/12

The European Medicines Agency bases its scientific opinions on the results of clinical trials carried out and submitted by pharmaceutical companies. The Agency has been releasing clinical-trial reports on request as part of its access-to-documents policy since late 2010 and is now working towards its goal of publishing clinical-trial data proactively for the medicines it has assessed. However, a number of policy and practical issues need to be resolved before this goal becomes a reality.

The Agency is committed to continuing to extend its transparency. A key goal in this process is the proactive publication of clinical-trial data for medicines once the decision-making process on an application for a European Union (EU)-wide marketing authorisation is complete.

Although the Agency is willing to deliver on this goal, there are a number of practical and legal implications that it needs to address and resolve first. It is therefore engaging in dialogue with its stakeholders to make sure that their views and concerns are taken into account.

This page summarises the current status of the Agency’s activities related to this project. The Agency keeps the page up to date as the project develops. read more