Life Sciences analysis: Julia Gillert, of counsel, Tanvi Shah, senior associate, and Jaspreet Takhar, senior associate, at Baker McKenzie discuss the proposed amendments to the legislative process for the conduct of clinical trials involving medicinal products in the UK
The Medicines & Healthcare products Regulatory Agency (MHRA) launched a consultation in early 2022 as part of its post-Brexit efforts to develop a world-class and flexible regulatory environment for clinical trials (see: LNB News 18/01/2022 90). The consultation closed in March 2022, but continues to offer insights into what the future holds for the UK regime for clinical trials.
It deals with improving the speed and efficiency of approvals of medicinal products, supporting innovation, enhancing transparency, encouraging greater risk proportionality, and promoting patient and public involvement in clinical trials. The proposals will result in updates to the current UK legislation governing clinical trials, the Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031 (as amended), which transposed Directive 2001/20/EC (the EU Clinical Trials Directive) into UK law. Having exited the EU, the UK is not subject to the EU’s long-awaited Regulation (EU) 536/2014 (the EU Clinical Trials Regulation), which entered into application across the EU on 31 January 2022, and which updates the EU Clinical Trials Directive, modernising and creating a more robust regime across the EU Member States.
The UK government also intends to update the UK’s requirements for compliance with the principles of Good Clinical Practice (GCP) in order to ensure that they are flexible and can be applied to a broad range of clinical trials, particularly from an international interoperability point of view.
In parallel, the UK also made a surprise proposal on 26 January 2022 for a new World Health Organization (WHO) resolution on clinical trials focusing on improving the capability of clinical trials, strengthening international collaboration and improving standards. This results from the coronavirus (COVID-19) pandemic, which according to the government’s Chief Medical Adviser, Chris Whitty, has exposed weaknesses in the clinical trials ecosystem, such as the failure to generate robust clinical evidence to inform decision-making and practice change.
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