# Clinical trials for medicines: roles and responsibilities

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/9c825de3-75fe-4eda-8dde-05b4a4a752a9
Type: Guidance
Published: April 16, 2026
Updated: July 7, 2026

> The UK Medicines and Healthcare products Regulatory Agency (MHRA) has finalized guidance for clinical trials, which became fully effective on April 28, 2026. This regulatory framework is established under the Medicines for Human Use (Clinical Trials) Regulations 2004 and the significant 2025 Amendment Regulations. While the provided text does not identify a specific company, inspection dates, or past violations, it mandates that all trial sponsors and investigators strictly adhere to all relevant official guidance throughout the lifecycle of a trial. According to Part 2 of Schedule 1, the primary requirement is that research parties must demonstrate regard for established standards when commencing and conducting clinical trials. Required actions for stakeholders include ensuring all trial operations are updated to comply with the 2025 amendments, as the guidance is no longer in draft form. This transition signifies that adherence to these standards is now a formal legal expectation for any human clinical research conducted within the United Kingdom, aimed at ensuring participant safety and trial integrity.

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## Content

The amended Clinical Trials Regulations took full effect on 28 April 2026. As such, this guidance should now be considered effective and is no longer in draft. The following guidance accompanies the Medicines for Human Use (Clinical Trials) Regulations 2004 , as amended by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 . Part 2 of Schedule 1 to the amended Clinical Trials Regulations requires that the investigator and sponsor have regard to all relevant guidance with respect to commencing and conducting a clinical trial.

## Attachments

- [Clinical trials for medicines: roles and responsibilities](/government/publications/clinical-trials-for-medicines-roles-and-responsibilities/clinical-trials-for-medicines-roles-and-responsibilities)