On 17th January 2022, the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) issued proposals to revise the current Medicines for Human Use (Clinical Trials) Regulations 2004 with the aim of improving and strengthening clinical trials regulation in the UK.1
The proposals have been developed by the MHRA and Health Research Authority (HRA), in collaboration with an Expert Working Group of stakeholders from across the clinical research sector, including patient representation. Further, the proposals as issued are open for public consultation until 14th March 2022 and, consequently, the timeline for implementation of these proposals remains unknown at this time.
The underlying rationale for the proposed revisions is to create a “world-class sovereign regulatory environment for clinical trials” with the UK now more than one year on from leaving the European Union following the conclusion of Brexit.
At present the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended, transpose the requirements of the EU Clinical Trials Directive 2001/20/EC into UK law. Consequently, the EU Clinical Trials Directive will be retired on 31st January 2025 following implementation of the EU Clinical Trials Regulation (Regulation (EU) 536/2014) on 31st January 2022.
| Patient and public involvement | Safety reporting |
| Research transparency | Good Clinical Practice |
| Clinical trial approval processes | Sanctions and corrective measures |
| Research Ethics review | Manufacturing and assembly |
| Informed consent in cluster trials | Definitions and other terminologies |
The proposed revisions to the UK regulatory framework for the approval and conduct of clinical trials are far ranging and will—to a certain extent—enshrine current working practices of the UK MHRA and RECs.
It is notable that the proposed revisions to the review and approval process may further streamline the time taken to attain approvals to initiate a study. Equally notable is that there is an emerging divergence from the framework adopted by the European Union with its implementation of the Clinical Trials Regulation.
1. MHRA, Clinical Trials and Investigations, Open Consultation. https://www.gov.uk/government/consultations/consultation-on-proposals-for-legislative-changes-for-clinical-trials
2. MHRA, Consultation on Proposals for Legislative Changes for Clinical Trials. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1046680/Clinical_trial_consultation_proposals_final.pdf
3. MHRA, Annex A – Legal basis and the assessment of the matters set out in section 2 of the Medicines and Medical Devices Act 2021. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1046710/Annex_A_-_legal_basis_final.pdf
Chris Ingram, BSc (Hons) is Head of Regulatory Consultancy (Europe) for Precision for Medicine. Chris received his BSc(Hons) in immunology and pharmacology from the University of Strathclyde and has since spent over 21 years working in regulatory affairs with a focus on clinical development. Chris’ regulatory expertise covers clinical development across all phases, regulatory strategy, marketing authorisations, scientific advice, orphan drug designation and paediatric investigation plans across a wide variety of therapeutic areas, including but not limited to, oncology, CNS, metabolic, endocrinology, analgesia and cardiovascular.
Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
