In October 2014, the European Medicines Agency (EMA) Board adopted the wording of the Agency’s new policy intended to further increase the availability of clinical trials data for medicinal products authorised in the EU:
- European Medicines Agency policy on publication of clinical data for medicinal products for human use
- Q&A on the European Medicines Agency policy on publication of clinical data for medicinal products for human use
This new policy aims to ensure that all clinical study reports supporting an application for a centralised marketing authorisation are systematically made public once the regulatory procedure for authorisation is concluded. By enabling the general public to access this data, it is hoped that these measures will contribute to increasing citizens’ understanding and confidence in the EU authorisation system for medicines.
This is the result of an extensive consultation phase launched in June 2013 when the Agency released the draft policy for a three-month public consultation.
For more information, please visit the EMA website.