Public consultation on documents in the context of the new Clinical Trials Regulation

Public consultation on documents in the context of the new Clinical Trials Regulation

The State Agency of Medicines informs that the European Commission (EC) has released for public consultation documents in the context of the new Clinical Trials Regulation (EU) No. 536/2014. Stakeholders are invited to send their comments by 31 August 2016 via e-mail to: SANTE-B4-GL-risk-proportionate-approach@ec.europa.eu

Documents for public consultation:

1. “Risk proportionate approaches in clinical trials”
2. “Summary of Clinical Trial Results for Laypersons”
3. “Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)” (previously called "Guidance on Investigational Medicinal Products (IMPS) and Non-Investigational Medicinal Products (NIMPs)”)
4. “Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors”

Documents are available on the EC website.