Clinical trial guidelines in public consultation
As a result of the EU’s new clinical trial regulation, the European Commission has submitted four guidelines for public consultation.
The following guidelines are available for consultation:
- Risk proportionate approaches in clinical trials
- Summary of clinical trial results for laypersons
- Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)
- Ethical considerations for clinical trials on medicinal products conducted with minors
You can find more information about the consultation and how to submit your contribution on the website of the European Commission. Contributions should be sent by 31 August 2016.
Read more about the public consultation