EMA Delays Adoption of Policy on Publishing Trial Data

July 9, 2014
The Pharm Exec staff

Pharmaceutical Executive

The European Medicines Agency (EMA) has postponed formal adoption of the policy on publication of clinical trial data.

The European Medicines Agency (EMA) has postponed formal adoption of the policy on publication of clinical trial data. An EMA press statement said that “[f]urther clarifications on wording and practical arrangements will be discussed by Board members”, whose additional contributions will now be considered with a view to reaching final agreement at the Management Board meeting on 2 October.

EMA referred to “the complexity of the debate on both political and technical aspects, which have emerged during the previous general and more targeted consultation phases”, adding that, in the last 12 months, it has “attempted to strike a balance between proactive data disclosure, the absolute need to protect personal data and the concerns relating to the protection of commercially confidential information.”

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