UK Law and Practice Contributed by: Jackie Mulryne, Ewan Townsend, Adela Williams and Libby Amos-Stone, Arnold & Porter
Following a public consultation undertaken by the MHRA in early 2022, new regulations (the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024) were laid before the UK parliament in December 2024 to amend the current UK framework governing clinical tri- als. The aim is to streamline clinical trial approv- als, enable innovation, enhance clinical trial transparency, enable greater risk proportional- ity, and promote patient and public involvement. The aim is for these changes to come into force by early 2026. Clinical investigations for medical devices are regulated by the UK Medical Devices Regula- tions. Requirements relating to clinical investiga- tions under the EU MDR and the EU IVDR apply in Northern Ireland. The amended regulations for medical devices, when introduced by the UK government, will also amend the requirements for clinical investigations. 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial Before a clinical trial for a medicinal product can commence, a REC must give a favourable opin- ion, and authorisation must be obtained from the MHRA. A sponsor of a clinical trial must be established in the UK or in a country on an approved country list, which includes EU/EEA countries. Otherwise, the sponsor must have a legal representative. As of 1 January 2022, applications for all new clinical trials for investigational medicinal prod- ucts must be prepared, submitted and reviewed via the combined review service – a single application route with co-ordinated review by the MHRA and the REC, leading to a single UK decision on the application. Applications must be submitted via the Integrated Research Appli- cation System (IRAS). While this single applica-
tion route is currently available in the UK through various schemes and pilots, it will be enshrined into law when the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 come into force. After receipt of a valid application, an assess- ment will be conducted within 30 days. Follow- ing assessment, and ordinarily within 60 days of the submission, the MHRA and the REC will either: • accept the request; • accept the request subject to conditions; or • not accept the request. The MHRA will focus on the safety and scientific value of the trial, while the REC will focus on the research proposals and review certain docu- ments relating to the trial, including the trial pro- tocol, the informed consent form, the suitability of the personnel, investigator and facilities, and the investigator’s brochure. The MHRA must be notified by the sponsor at least 60 days in advance of the commence- ment of a clinical investigation involving medical devices. Applications should be submitted via the IRAS. The MHRA will consider the documen- tation and assess the safety and performance of the device, as well as the design of the investiga- tion. A letter will be sent to the sponsor within 60 days with a decision (providing either an “objec- tion” or “no objection” ). In addition, an opinion of the REC is required. 2.3 Public Availability of the Conduct of a Clinical Trial Any favourable opinion by a REC is conditional upon the clinical trial being registered on a pub- licly accessible database.
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