The UK Parliament and Northern Ireland Assembly approved changes to the law governing the regulation of clinical trials involving investigational medicinal products (CTIMPs) across England, Wales, Scotland, and Northern Ireland.

In parallel, the Health 69色情片 Authority, has introduced new expectations on how non-CTIMPs (i.e. clinical trials testing medical devices, public health measures, behavioural therapies or any other types of health and social care research), need to be managed to support transparency, patient safety and research integrity.

An overview of the main changes is summarised below:

  • is now aligned with international standards and clarifies the level of review required for each type of modification: 鈥檃mendment鈥� has been replaced with 鈥榤odification鈥�, categorised as 鈥榮ubstantial鈥�, 鈥榠mportant detail鈥�, or 鈥榤inor'; trial site鈥� will be referred to as 鈥榯rial location鈥� and 鈥榮ubject鈥� as 鈥榩articipant鈥�
  • remains a condition of a REC鈥檚 favourable opinion but for involving medicines will be a legal requirement. A study will need to be registered before the first participant is recruited or within 90 days of approval (whichever is earlier). Registration databases: (preferred) or
  • for the approval process have been clarified ; streamlining NHS staff studies and for modifications (amendments).
  • for 69色情片 Ethics Committees (RECs) are clarified, with and adjustments to the quorum rules
  • New provisions allow for low-risk trials, to reduce barriers to participation while maintaining informed decision-making
  • reporting obligations are updated to align with international standards. Sponsors will need to follow enhanced procedures for reporting adverse events, ensuring timely identification and response to safety signals across all clinical trials.

More details can be found on the HRA website: and University webpage Obtaining Sponsorship from the University of Bath - guidance.

A webinar was held on 12 March jointly presented by HRA and MHRA which covered the key changes in the updated regulations, the transitional arrangements and guidance. A recording of this webinar is available via the .

For details how these changes impact clinical trials of investigational medicinal products (CTIMPs) please refer to the . Additionally, the contains guidance, news, and other useful information.

Future changes:

  • The HRA is reviewing changes to the model Clinical Trial Agreement (CTA) and other applicable model agreements.
  • A new digital service, , will be introduced in 2027 to streamline applications and processes replacing IRAS.

Information will be provided when released by the HRA. To be kept up to date with clinical trials news from the HRA please .