Following two meetings with drug companies and other stakeholders in July and September, the European Medicines Agency (EMA) says it will publish the first clinical trial reports in mid-2016.
The release of the reports comes as EMA’s policy on publishing the data came into effect last January. The new policy applies to clinical reports contained in all marketing-authorization applications submitted on or after 1 January 2015, and includes reports where drugmakers have notified EMA of the withdrawal of a marketing authorization application.
In addition to the implementation of EMA’s transparency policy, the European Commission, EMA and World Health Organization announced Tuesday that they agreed on 1 September to share more non-public information on the safety, quality and efficacy of already-approved drugs.
To read the article by Zachary Brennan