In the context of Britain’s recent decision to leave the EU, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has invited any interested parties to provide feedback on their new clinical trial guidance documents by the end of August 2016. According to the call:

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’.

There are currently four European Commission consultations underway on guidance documents that have been developed in preparation for the implementation of the Clinical Trial Regulation (EU) No 536/2014, all of which have an August 31st deadline:

  • 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”.

The MHRA’s call for consultation input can be found here.

The full documents can be found on the European Commission Website.