GovWire

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.

This consultation seeks the views of stakeholders and other interested parties on the document regarding Risk proportionate approaches in clinical trials. The main objective of these recommendations is to provide further information on how a risk proportionate approach can be implemented in clinical trials and also highlights the areas identified in the clinical trials Regulation which support and facilitate such adaptations.

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:

• 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;
• 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));
• Revision of Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors; and
• 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.

Your comments are welcomed by e-mail to the relevant address for each document:

• Risk proportionate approaches SANTE-B4-GL-risk-proportionate-approach@ec.europa.eu
• Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs) SANTE-B4-GL-IMP-AMP@ec.europa.eu
• Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors SANTE-B4-GL-Ethics-Minors@ec.europa.eu
• Summary of Clinical Trial Results for Laypersons SANTE-B4-GL-results-laypersons@ec.europa.eu

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