EMA news

EMA policy to publishing and access to the data from clinical studies.

Requirements not only for transparency of the decisions and events adopted by the European Medicines Agency (EMA), but also for transparency of the data from clinical trials/studies, which its regulatory decisions are based on, are of ascending character.
In the mid 2013 EMA published the draft rules for publishing and access to the data from clinical trials submitted within the scope of application for marketing authorization of the medicinal product.
Comments to the draft could be mailed within 30.09.2013.
The document will come into legal force from January 2014.

The document can be leafed through here.


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