EMA guidance on publication and access to clinical trial data expected in 2014

Discussions on publication and access to clinical trial data are on schedule to be published in 2014 after the European Medicines Agency (EMA) said it has reviewed all comments on its draft policy.

While the comments received showed that there is large support for the EMA’s plans to allow access to clinical trial data submitted as part of marketing authorization applications, they also highlighted that there is a need for further analysis and clarification of certain aspects.

Protecting patients’ identification