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New EU Regulation on Clinical Trials on Medicinal Products

By Epstein Becker Green on April 16, 2014
Posted in Articles

By Daniel G. Gottlieb

On April 2, the European Parliament voted overwhelmingly to repeal the current EU Directive on clinical trials of medicinal products for human use and replace it with a new Regulation.  The primary goals of the new Regulation are to:

  1. Streamline the approval process for studies conducted across multiple Member states;
  2. Harmonize

…

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