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Clinical trials of medicines and advanced therapies

The Medicines and Healthcare products Regulatory Agency (MHRA) consultation on proposals for legislative changes for clinical trials closed in March 2022. MHRA are currently analysing responses.

Clinical trials regulation – know the basics

Trials within the scope of the clinical trials regulations are called clinical trials of investigational medicinal products (CTIMPs): MHRA tend to refer to them just as ‘clinical trials’.

UK clinical trials regulations apply to trials that test the safety or efficacy of medicinal products, including medicines, vaccines, gene and cell therapies, etc. If you are planning an experimental medicine study, exploring mechanisms of action, the regulations may not apply. Our experimental medicine toolkit has more on these.

It isn’t always easy to determine if your trial is within scope of the UK clinical trial regulations. See MHRA guidance When a clinical trial authorisation is needed.

It is a legal requirement to have a sponsor for a CTIMP. In academic trials this is generally the employer of the chief investigator (it’s unlikely to be the funder). Sponsors have legal obligations and corporate systems in place to manage these.

Your trial must get approval from the relevant department in the sponsoring organisation. In Universities this could be the university ‘research governance’, ‘research integrity’, ‘research ethics’ or ‘sponsor’s’ office. In the NHS, it is usually the NHS ‘research and development’ or ‘R and D’ department.

Other approvals include the clinical trial authorisation (CTA) from the MHRA and NHS research ethics committee (REC) approval, obtained as a combined review from a new part of IRAS.

If your trial involves the NHS, or HSC in Northern Ireland, then you will need appropriate approvals or permissions for this. Further guidance is provided in the ‘approvals for clinical trials’ section.

It is a legal requirement to work to the principles of good clinical practice (GCP). If you are conducting a trial with commercial partners and the data will be used to support a marketing authorisation, you are likely to meet the more prescriptive demands of ICH GCP.

You must register your CTIMP and publish your results.

See the Clinical trials toolkit for guidance on the legal requirements for CTIMPs.

UK clinical trials regulation

Overview of MHRA requirements for UK clinical trials. Certain aspects are highlighted below. MHRA scientific advice for medicines, including clinical trial advice.

Is it a clinical trial of an investigational medicinal product?

Please read:

Approvals for clinical trials

Guidance on MHRA and HRA approvals can be found here:

The combined review service brings together a single CTIMP application for both clinical trial authorisation and research ethics committee opinion obtained from a new part of IRAS.

The MHRA has published common problems with clinical trial applications and guidance on how to avoid them: Common issues identified during clinical trial applications.

Your clinical trial sponsor is responsible for submitting your clinical trial application to the MHRA. (Clinical trial sponsors must register to make submissions to the MHRA.)

Amendments and reporting

If you make changes to your trial after approval, an ‘amendment’, then the MHRA (and others) may need to know about this. For further guidance on amendments, see:

Change of principal investigator at an NHS site (or HSC site in Northern Ireland) or the addition of an NHS or HSC site are no longer substantial amendments see Key changes to UK amendment process.

Your clinical trial sponsor is responsible for submitting substantial amendments to the MHRA.

There are various reporting requirements for clinical trials (for example safety reports, progress reports and end of trial notifications). For further guidance, see HRA managing your approval.

Your clinical trial sponsor is responsible for submitting end of trial notifications and developmental safety update reports (DSURs) to the MHRA.

If you are a clinical trial sponsor MHRA guidance for sponsors on submitting clinical trial safety reports is useful, this includes information on the transition between reporting to EU and UK systems.

Importing and exporting

If you need to import or export clinical trial supplies for your trial, you should contact your clinical trial sponsor.

If you are a clinical trial sponsor you may find the following resources useful:

Trials with sites in the EU

For clinical trials in the EU, your clinical trial sponsor can now make submissions on the Clinical Trials Information System. The EMA is providing training for the new system.

Additional information specific to advanced therapies

MHRA provides guidance on advanced therapy medicinal products regulation and licensing, including how to get Regulatory advice for regenerative medicines.

The Human Tissue Authority (HTA) human application pages will be useful for those developing cell and tissue-based therapies. HTA regulates those undertaking procurement, testing, processing, storage, distribution, import and export of tissues and cells for human application.

If using human embryonic stem cells for human application, please read joint guidance from the HTA, HFEA and MHRA.

Information around advanced therapies in the EU can be found on the EMA website. A good overview of the EU (also US and Japan) regulatory framework can be found in the following resources:

Last updated: 19 August 2022

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