New recommendations for the implementation of the Clinical Trial Regulation

The European Commission has recently published three recommendations for the implementation of regulation (EU) No 536/2014 on clinical trials on medical products for human use (the Clinical Trial Regulation). The recommendations are written by the expert group on clinical trials, which has been set up by the European Commission.

The Clinical Trial Regulation establishes an EU portal and database that will harmonize the assessment and supervision processes for clinical trials throughout the EU. When the regulation enters into application, applicants only have to apply for clinical trials via the EU portal instead of having to submit applications in each member state. All clinical trial information will be stored in the database, which will be publicly available. The public will hereafter be able to find all information on clinical trials conducted in the EU.  

The EU Clinical Trial Regulation is expected to enter into application in the second half of 2019.

The Clinical Trial Regulation can be found here

Find the recommendations here:

• Auxiliary medicinal products in clinical trials (revised June 2, 2017) (previously called Guidance on Investigational Medicinal Products (IMPs) and "non investigational medicinal products" (NIMPs) (revised March 1, 2011))
• Risk proportionate approaches in clinical trials (dated April, 2017)
• Summaries of Clinical Trial Results for Laypersons (January, 2017)