EMA Transparency: Clinical Trials Publishing

The European Medicines Agency (EMA) has proactively started publishing clinical trials data, with the release of clinical reports for 2 drugs, Kyprolis and Zurampic, via a new online database.

Clinical trials transparency has been a concern of public health advocates and regulators for decades. Specifically, EMA says it will publish the clinical overview, summary and study reports, including data from several appendices (protocol and protocol amendments, sample case report forms and documentation of statistical methods) for all marketing authorisation applications, so-called Article 58 procedures, as well as applications for new indications and variations to already-approved drugs.

Going forward, EMA says it will work to tackle the backlog of clinical reports for marketing authorisation applications and variations submitted after the policy went into effect (1 January 2015 for initial marketing applications and 1 July 2015 for variations).

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Published on 21. October 2016 in News EU