The EU Commission is currently consulting on the following documents developed in preparation for the implementation for the Clinical Trials Regulation (EU) No 536/2014.
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"
GL-4: "Risk proportionate approaches in clinical trials"
The Welsh Government is intending to submit a coordinated UK-wide response with the HRA and other devolved administrations.
Please forward any comments on all or any these documents to Claire Bond Claire.Bond@wales.gsi.gov.uk.
Deadline for comments: Friday 5 August 2016
All comments will be consolidated into a unified response.