This is the second of a series of blogs celebrating International Clinical Trials Day 2026. In our first instalment, we looked at the history of clinical trials. In this blog, we will explore the impact of recent reforms to global clinical trials regulations. This series leads into our Masterclass on Medical Monitoring which you can find linked at the bottom.

Clinical Trial Reform: the Global Stage

The latest reforms to international clinical trial regulations represent a seismic shift in the expectations on medicines developers.

Good Clinical Practice (GCP) was established by the International Conference on Harmonisation (ICH) in 1996, with the ICH GCP E6 guideline. This was the foundational international ethical and quality standard for designing, conducting, and reporting clinical trials intended for regulatory submission. GCP ensures the rights, safety, and well-being of trial participants while supporting the credibility of clinical trial data. It has been updated several times since then but this latest revision, ICH E6(R3), the culmination of years of consultation and review, brings GCP firmly into the modern world.

The emphasis is now on Quality by Design with proactive, risk-proportionate oversight, and all clinical trials (not only those intended for submission) are subject to this regulation. A new section on data governance, guidance on novel trial designs, a focus on patient involvement and participant diversity, and updates to the founding principles reflect recent changes to the nature of clinical research.

This updated guideline was published by ICH on 06 January 2025 and has been adopted into local legislation in many countries since then, for example the EMA adopted ICH E6(R3) in July 2025 and the FDA adopted this update in September 2025.

Some Regulatory Agencies, such as the UK Medicines and Healthcare products Regulatory Agency (MHRA), have taken the opportunity to incorporate other updates to their laws, making this an exciting time for clinical research!

UK Perspective

The UK’s updated clinical trial framework came into force on 28 April 2026 under the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, introduced by the MHRA and the Health Research Authority (HRA).

The changes are intended to improve efficiency while maintaining a clear focus on participant safety and GCP. Since Brexit the UK has been working to make sure it maintains its place in global clinical development, and MHRA published data showing that they have reduced clinical trial set-up timelines from 169 to 122 days (28% reduction), driven by operational improvements such as combined regulatory and ethics review.

The new framework now formalises and builds on this progress, introducing:

• Risk-proportionate pathways for lower-risk trials;
• Innovative use of technology;
• Mandatory requirements for trial registration and results reporting.

From an industry perspective, these amendments create opportunities to accelerate clinical development and it enhances the UK’s position as a competitive research environment.

However, the updates also clarify the responsibilities of the developer, providing an updated framework for inspection. Overall there is an expectation of a more considered approach, integrating risk-proportionate clinical oversight and data governance into clinical development programmes. In return for shorter timelines and increased flexibility there is greater emphasis on:

• Aligned regulatory strategy, particularly in adapting to revised approval pathways;
• Robust pharmacovigilance frameworks to support timely and consistent safety evaluation;
• Clear benefit–risk communication across submissions and study documentation;
• Sustained inspection readiness, supported by strong data integrity and operational controls.

At Pharmora we provide medical monitoring services to support Sponsors of clinical trials, and help design clinical development programmes to align with the latest regulations for the greatest chance of success.

Feel free to reach out for a no-obligation conversation to explore how Pharmora could support your clinical research plans.