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17 March 2022

Future of United Kingdom clinical trial legislation and impact on IMP’s

Future of United Kingdom clinical trial legislation and impact on IMP’s

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation that run from 17th of January until 14th of March 2022 on a set of far-reaching proposals to improve and strengthen the United Kingdom (UK) clinical trials legislation to make the UK the best place to research and develop safe and innovative medicines. Due to the Brexit, the EU Clinical Trial Regulation is not (directly) applicable in UK.

Clinical trials are vitally important for achieving advances in medical treatment. Clinical trials may be conducted for a range of purposes, for example to test whether a new treatment or combination of treatments is safe and effective, or to explore new ways to use existing medicines – as has been seen with the rapid introduction of new vaccines and therapeutics for COVID-19.

Through the proposals outlined in this consultation MHRA aims to reframe the legislation that underpins UK regulation of clinical trials to deliver a more streamlined, transparent, and flexible regulatory regime whilst always protecting patients and trial participants. In line with the ambitions of the Life Sciences Vision these proposals for UK legislation seeks to make the UK the leading global centre for innovative research design and delivery, across all types of trials. The proposals are to update the current UK legislation that governs Clinical Trials (CTs), The Medicines for Human Use (Clinical Trials) Regulations (2004 No. 1031), which transposed the former EU Clinical Trials Directive 2001/20 into UK law. The proposal is based on feedback from stakeholders and an Expert Working Group, which included representatives from academia, industry, and patient groups.

UK requirements will remain unchanged pending completion of the consultation. However, UK will remain aligned with the internationally harmonized standards of PIC/S and the EU, including requirements for the Qualified Person. The revised Annex 13 Manufacture of Investigational Medicinal Products changes the approach to the management of issues at the interface between GMP and GCP. These include the two-step release procedure, handling and shipping of IMPs and contractual arrangements between the sponsor and the IMP manufacturer. There are also changes to the labelling of IMPs (e.g., changing the approach to providing expiry information, moving labelling requirements from GMP guidance into the text of the CTR).