Clinical Trials: UK regulatory landscape set for change
On 12 December 2024, a significant milestone was reached in the evolution of the UK’s clinical trial landscape as the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 were laid before Parliament for debate (the “Updated Regulations”). The Updated Regulations are set to amend the UK’s existing regulatory framework, marking a pivotal shift in how clinical trials are conducted in the UK.
With a 12-month implementation period, the Updated Regulations are expected to come into force in January 2026. We set out below some of the key changes contemplated by the Updated Regulations and their potential impact on the clinical trial environment in the UK.
Reform objectives
In reforming the UK’s clinical trial regulatory framework, the Government’s key objectives include the following:
- Global competitiveness: Positioning the UK as an attractive location for clinical trials, enabling it to compete on a global stage;
- Regulatory flexibility and proportionality: Introducing a more flexible and proportionate regulatory framework aimed at streamlining processes while promoting patient safety; and
- Reducing regulatory burden: Easing the overall regulatory burden on trial sponsors, particularly where trials are considered lower risk, to foster efficiency and innovation.
Key proposed changes to the regulatory framework
- Streamlined combined review and approval process
- New notification process for lower risk trials
- New transparency requirements
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