MHRA Newsletter January 2026

30th January 2026

Summary: The January 2026 edition of MHRA News reflects the agency’s priorities and recent progress across medicines, medical devices and clinical trials. It emphasises ongoing clinical trial reform efforts aimed at making the UK more attractive for research and helping patients access new treatments sooner, with faster assessment pathways and new routes coming into effect.

Stakeholders are reminded of the final call for evidence on AI regulation in healthcare, with submissions due by 2 February 2026, to inform future UK policy frameworks.

Performance data shows continued strong delivery against statutory timelines for licensing, clinical trials and other regulatory services, with a shift to reporting median timelines to improve transparency and accountability.

Other highlights include:

• MHRA begins its term as Chair of the Access Consortium for 2026, boosting international regulatory cooperation.

• A new pilot fee waiver programme for clinical investigation applications is open to micro and small enterprises to encourage innovation.

• Updated guidance on medical device conformity assessment routes and UKCA marking has been published to aid manufacturers with classification and compliance.

• Events and resources such as a webinar on standards for biological medicines and a study on polio vaccine stability are featured.

• Safety updates include reaffirmed guidance on paracetamol use in pregnancy and revised isotretinoin risk-minimisation measures.

• Enforcement actions highlighted include the seizure of nearly 20 million illegal medicine doses in 2025.

• A reminder that new UK clinical trial regulations take effect on 28 April 2026 and draft guidance has been published on related topics including Good Clinical Practice and clinical trial records.

Link: https://content.govdelivery.com/accounts/UKMHRA/bulletins/4061832

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