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European Medicines Agency Adopts Policy on Publication of Clinical Data for Medicinal Products

October 2014

Focus on Regulation - Hogan Lovells Blog

On 2 October 2014, the European Medicines Agency (EMA) adopted its long awaited policy on the publication of clinical data for medicinal products (the Policy). Under the Policy, the EMA will proactively publish on its website clinical data submitted as part of an application for marketing authorization for medicinal products through the centralized procedure. The clinical data shall be published following completion of the decision-making process.

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