European Medicines Agency

The European Medicines Agency (EMA) issued guidance on the implementation of its Policy 0070 on the publication of clinical data for medicines, including with respect to anonymization of clinical reports for publication. (As background, please see our previous briefing on the EMA’s new approach to transparency of clinical studies here.) As of October 2016, all drug manufacturers that are making a marketing authorization application under the centralized procedure in Europe will be subject to the new guidance.[1]