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Pharma Compliance Info EMA to Publish First Clinical Trial Reports in Mid-2016 Under New Transparency Law Open Data

EMA to Publish First Clinical Trial Reports in Mid-2016 Under New Transparency Law

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

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