The EU Commission’s Directorate General for Health and Food Safety (DG SANTE) Clinical Trials Regulation has recently consulted on four documents developed in preparation for the implementation for the Clinical Trials Regulation (EU) No 536/2014.
Our response to each of these documents can be found here:
- GL1: Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors
- GL2: Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)
- GL3: Summary of Clinical Trial Results for Laypersons
- GL4: Risk proportionate approaches in clinical trials