Welsh Government

Clinical trials public consultation - call for responses

7 Gorffennaf 2016

Mae’r digwyddiad hwn wedi dod o wefan allanol ac mae ar gael yn Saesneg yn unig.

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.

These are:

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.