Recently our one of our Regulatory team went to a talk on the how the new UK Clinical Trial regulations will be implemented in the upcoming months. The talk consisted of legislative updates, plans for developing guidance and a clinical trial road map. Some areas are already underway, but the majority are still in the development stages.

The following information is an overview of what was discussed and a summary of how things will change moving forward.

1. Legislative Updates

Regulatory reform in clinical trials under way.

Four main themes: ensure patients and safety are at focus of clinical trials; create proportionate and flexible regulatory environment; cement UK as destination for international trials; provide a framework that is streamlined, agile and responsive to innovation.

2. Changes to Approval Process

More streamlined and efficient application process

Coordinated ethics and regulatory review; single UK decision for clinical trials.

A notification scheme for clinical trial applications and modifications to be implemented.

3. Changes to Research Transparency

Registration in a public registry before recruitment of first participant.

Publication of a summary of results within 12 months of the end of the trial.

4. Changes to GCP

Update the provisions on GCP to align with ICH guidelines, ensuring that clinical trials in the UK continue to meet international standards.

5. Changes to Manufacturing and Assembly

Detailed definition of non-investigational medicinal products to be added.

Extended exemption for requirement of specific MAs for an investigational medicinal product to include radiopharmaceuticals.

6. Changes to Safety Reporting

Removal of duplicative reporting requirements.

Remove the requirement to include listings of certain adverse events and instead an ongoing summary to be implemented.

Legislation currently expected to be implemented in January 2026 after a transitional period.

7. Health Research Authority Guidance

New regulations will include provisions for increased transparency.

8. Clinical Trials Roadmap

New guidance being drafted now; published guidance to become available in Q1 2025. Workshops and stakeholder collaboration to be part of guidance development.

Good Clinical Practice ‘Grey Guide’ not being replaced at the moment.

MHRA website will have new guidance shared on it.

Existing trials submitted before the change date will be subject to old regs, but this will be clarified in transition period. Modifications will be subject to new procedure.

Regulations to cover all UK countries.

Modifications, now amendments, are split into three levels of severity; non-notifiable, notifiable and substantial. Non-notifiable to be small admin type changes that only need to be sent to sponsor and not MHRA.