Long-Awaited EU Clinical Trials Portal Meets Major Milestone
A simplified process for registering and evaluating clinical trials promised by the EU Clinical Trial Regulation is finally set to become a reality.
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The European Medicines Agency is expecting a lively pipeline of advanced therapy medicines over the next few years. It is also making final preparations for the introduction of the new EU clinical trials system from the end of January next year.
The European Medicines Agency is inviting feedback on changes to two guidelines that will help trial sponsors correctly classify quality-related changes to their investigational medicinal products as per the requirements of the EU Clinical Trial Regulation.
Having gained enough experience with the combined ethics and regulatory review of clinical trial applications, the UK will make this its only route for evaluating new drug trial applications starting next year.