New EU Clinical Trial Regulation’s Streamlined Approval Process May Not Be ‘One Size Fits All,’ in Bloomberg BNA’s Life Sciences Law & Industry ReportMay 16, 2014
Daniel Gottlieb, an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office, wrote an article titled "New EU Clinical Trial Regulation's Streamlined Approval Process May Not Be 'One Size Fits All.'"
Following is an excerpt:
The European Parliament—the directly elected parliamentary body of the European Union—voted overwhelmingly on April 2 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 the regulation of clinical trials throughout the member states; and
3. Increase transparency of clinical trial results.