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.
Key objectives for the proposed revisions2
Promote public health and ensure protection of participants remains at the heart of legislation
Remove obstacles to innovation whilst maintaining robust oversight of the safety of trials
Streamline the regulation of clinical trials and reduce unnecessary burden to those running trials by embedding risk proportionality into the framework
Facilitate the evaluation and development of new or better medicines to reduce the burden of disease on patients and society
Ensure the legislation builds international interoperability so that the UK remains a preferred site to conduct multi-national trials
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.
The proposed revisions of the current UK regulations for clinical trials focus on the following key areas:
Patient and public involvement
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.
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.