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Regulatory Focus™ > News Articles > EMA Set to Finalize Clinical Trials Transparency Policy

EMA Set to Finalize Clinical Trials Transparency Policy

Posted 09 April 2014 | By Louise Zornoza

The European Medicines Agency (EMA) announced on 8 April 2014 that it plans to launch a final round of meetings in May with organizations representing patients, academia, the pharmaceutical industry and European Union (EU) institutions before finalizing its clinical trials transparency policy. 

The intent is to "fine tune" specific aspects of the policy, such as the possible redaction of the clinical study reports for those parts of clinical trial data that exceptionally contain commercially confidential information.  The agency also plans to clarify how it will communicate with the sponsors before any disclosure of their data, as well as how the data will be made publicly accessible.

The agency specifically clarified that it is "committed to pursuing the objective of full transparency regarding clinical trial data because it believes that the release of data contributes to establishing trust and confidence in the system." 

EMA intends to present the final form of the policy to its Management Board for approval in June 2014.

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