The table below details the Timeline of proposed changes to the regulatory framework for clinical trials in the UK.
| Date(s) | Event | Notes |
|---|---|---|
| 17 Jan -14 Mar 2022 | MHRA public consultation on proposals for legislative changes for clinical trials. This consultation specifically concerned clinical trials and the medicinal products used in clinical trials (Investigational Medicinal Products, ‘IMPs’). The public consultation sought the views of patients, clinical trial participants, researchers, developers, manufacturers, sponsors, investigators, healthcare professionals, and the wider public. Responses were received from a total of 2138 respondents, 88% from individuals and 12% from organisations. | These proposals are to improve and strengthen the current UK legislation that governs clinical trials, The Medicines for Human Use (Clinical Trials) Regulations 2004” (SI 2004/1031), as amended, which transposes the EU Clinical Trials Directive 2001/20 EC into UK law. |
| 21 Mar 2023 | Government response to consultation on legislative proposals for clinical trials published. | Having analysed over 2000 responses received, the government will take forward legislation to reform of the UK clinical trials regulatory framework that will: · Ensure patients and their safety are at the focus of all clinical trials and bring the benefits of clinical trials to everyone · Create a proportionate and flexible regulatory environment · Cement the UK as a destination for international trials · Provide a framework that is streamlined, agile and responsive to innovation |
| 25 May 2023 | Commercial clinical trials in the UK: the Lord O’Shaughnessy review – final report | This review was commissioned to offer recommendations on how commercial clinical trials can help the life sciences sector unlock UK health, growth and investment opportunities. The sector was also asked to advise on how to resolve key challenges in conducting commercial clinical trials in the UK. Extensive engagement with leaders from industry, medical research charities, academia, the NHS, regulators and other partners in clinical trials has highlighted a high degree of consensus about both the areas of UK success, and where action is needed to further competitiveness. The 27 recommendations of the review are set out in the report. |
| 13 June 2023 | Independent review into UK clinical trials – Oral evidence | Here, you can view the parliament session and/ or read the transcript on the oral evidence. |
| 4 July 2023 | MHRA published its corporate plan 2023-2026. | Clinical trials are mentioned in this report, for example : 1) The MHRA aims to involve patients at every step of the regulatory process to ensure that the balance of risk and benefit is considered from all perspectives. This will require developers to demonstrate that they have consulted patients in the development of new products and the design of clinical trials and investigations. 2) Developers, manufacturers and distributors of medicines and medical devices rely on the MHRA to provide robust decisions in predictable timeframes for high-quality applications in clinical trials and investigations. The introduction of new legislation and guidance for clinical trials, medical devices, and point of care manufacturing is critically important to attracting innovative products, whilst also providing the stable and predictable regulatory environment that companies require. By working with partners across UK health ecosystem, the MHRA will create faster risk-proportionate, and predictable regulatory pathways. |
| Autumn 2023 | Expected drafting of Statutory Instrument that will update the clinical trials legislation | |
| By 31 Mar 2026 | It is expected that a revised regulatory framework for clinical trials will be in place. | MHRA corporate plan 2023-2026, point no 2 Enable healthcare access to safe and effective medical products, Year 3: 2025/26 (to be completed by 31 March 2026), sub point 2.9 Implement a revised regulatory framework for compliance. |
Sources:
- UK MHRA
- gov.uk
- parliament.tv
- Legislative change is afoot for clinical trials conducted in the UK, By Jackie Mulryne, Eleri Williams & Sofia Wilson, 21 July 2023, Bioslice Blog, Arnold & Porter.