The UK Medicines and Healthcare products Regulatory Agency (MHRA) is set to launch a pilot aimed at refining the approval process for amendments to clinical studies.
This trial period, scheduled from 1 October 2025 to 31 March 2026, is in anticipation of the forthcoming clinical trials regulations that will be implemented on 28 April 2026.
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The pilot is designed to broaden the UK regulator’s risk-adjusted approach by incorporating the assessment of changes to already sanctioned clinical trial applications.
With the upcoming regulations, significant alterations could receive automatic consent through the Route B substantial modification procedure, provided they meet the determined eligibility criteria.
As the new regulatory framework is introduced, the current voluntary notification system for Type A trials will be discontinued on 30 September 2025.
These Type A trials relate to medicinal products that are licensed in any European Union (EU) Member State and are associated with a range of indications, dosages, and forms.
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By GlobalDataThe forthcoming regulations will merge the notification scheme for Type A trials and the new scheme into a single category known as Notifiable Trials.
Modifications that comply with section 11B of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 are eligible for inclusion.
By taking part in the pilot, sponsors will not only receive a decision from the regulator regarding their amendment within 14 days but also gain familiarity with the eligibility requirements.
The latest regulations, ratified by UK Parliament in April this year, aim to establish a flexible and patient-focused regulatory framework.
In conjunction with the Health Research Authority (HRA), the MHRA formulated the legislation, incorporating feedback from stakeholders through a public consultation.
The forthcoming changes will apply solely to new applicants, with existing applications proceeding under the current protocol.
In June, the UK Government disclosed its ’10-Year Health Plan’, which is designed to accelerate clinical trials and revolutionise patient care.
