European Medicines Agency [to 5 March 2016]
http://www.ema.europa.eu/

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03/03/2016
Guidance for the publication of clinical data
Requirements for industry now available on submission of clinical data for publication

The European Medicines Agency (EMA) has published detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of clinical data.
EMA’s pioneering policy entered into force on 1 January 2015 and applies to clinical reports contained in all marketing-authorisation applications submitted on or after this date. The first reports are currently foreseen to be publicly available in September 2016.

“With this guidance, the Agency is moving towards the operational implementation of its proactive publication policy, which launched a new era of transparency,” says Noël Wathion, EMA’s Deputy Executive Director. “The guidance will ensure that companies are aware of what is expected of them and are ready for the publication of these critical data.”…