EMA’s Implementation of Policy 0070: Highlights From Year One

The European Medicines Agency (EMA) published its first report on the implementation of Policy 0070 for the publication of clinical data. As of October 2016, the EMA publishes clinical data submitted by pharmaceutical companies to support their regulatory applications for human medicines under the centralized procedure. The 27-page report, published July 16, 2018, covers one year from the launch o ...

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