Clinical Trials Regulations – have your say

There are currently four consultations on guidance documents that have been developed in preparation for the implementation of the Clinical Trial Regulation (EU) No 536/2014. The MHRA GCP Inspectorate encourages you to take time to review these.

Following the EU referendum, MHRA continues to play a full, active role in European regulatory procedures. The UK is assessing the potential impact on our regulatory framework of the decision to leave the EU.  At present, we continue with our programme for implementing the Clinical Trials Regulations and we remain an EU Member State with the rights and responsibilities this entails.

The four consultations on guidance documents that have been developed in preparation for the implementation of the Clinical Trial Regulation (EU) No 536/2014 are:

1. “Risk proportionate approaches in clinical trials” - providing further information on how a risk proportionate approach can be implemented in clinical trials and highlighting areas within the clinical trials Regulation which support such adaptations;

2. Revision of the "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));

3. Revision of "Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors”; and

4. "Summary of Clinical Trial Results for Laypersons".

These are currently out for public consultation from 1 June 2016 to 31 August 2016

The documents are available on the European Commission website

Do not send your contribution to the MHRA. Please submit your contributions by e-mail to the relevant address for each document:

1. “Risk proportionate approaches” - SANTE-B4-GL-risk-proportionate-approach@ec.europa.eu

2. "Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)" - SANTE-B4-GL-IMP-AMP@ec.europa.eu

3. "Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors” - SANTE-B4-GL-Ethics-Minors@ec.europa.eu

4. "Summary of Clinical Trial Results for Laypersons" - SANTE-B4-GL-results-laypersons@ec.europa.eu

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Access our guidance on good practice for information on the inspection process and staying compliant.