Frequently asked questions

What are the UK regulations?

The Medicines and Healthcare Regulatory Agency (MHRA) is the competent authority that regulates CTIMPs in the UK. Before a trial can begin, it is important to confirm whether it falls within the scope of the Medicines for Human Use (Clinical Trials) Regulations 2004, which together with its amendments, are referred to as the Clinical Trial Regulations within this Toolkit. The MHRA has produced an algorithm (.PDF) to help researchers determine whether their trial is a CTIMP.

Researchers planning a CTIMP should be familiar with the MHRA Clinical Trials Pages to help ensure all legal requirements are considered.

The European Directive (2001/20/EC) no longer applies in the UK. The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004 to enable the MHRA to operate as a regulator outside the EU.

The MHRA has published new guidance for clinical trials for organisations to follow.

 

What are the transitional arrangements for a trial that began before the arrangements were introduced in 2004?

The MHRA agreed transitional arrangements for clinical trial authorisations. They also agreed transitional arrangements for manufacturers to apply for licences to manufacture IMPs. Nearly all currently authorised clinical trials were converted to “Clinical Trial Authorisations” without any further application. For a few trials, more information may be required if they are with unlicensed products on which there is insufficient data to meet the new requirements. The MHRA recruited additional staff to handle the increased number of applications.