Medicines and Healthcare products Regulatory Agency (MHRA)

PV teams must prepare and finalize safety-related briefing materials, including risk management plans and protocols, for initial submission by September 2026.

Manufacturers must submit renewal applications for CTDA certificates with a £420 fee (discounted to £168 for small organizations) and respond to any requests for additional information within 20 working days.

Clinical safety teams are required to review and implement the updated guidelines, ensuring that workflows for MRI equipment safety are compliant with the latest standards, particularly focusing on UKAS accreditation.

Verify inventory of affected RelayPro Thoracic Stent-Graft System lots (model 28-N4-XX-XXX-XXS) and implement actions per the FSN document.

Check for affected batches of Mirtazapine 30mg Tablets as described in EL(26)A/28 and implement any necessary quarantining or recall steps.

Review adverse event reports for potential links to counterfeit weight loss medicines; check product supply chain for unlicensed sources.

Developers of MBMPs must align their safety assessment protocols with the MHRA's expectations and are encouraged to engage with the MHRA early to establish appropriate regulatory strategies.

Manufacturers must review and align their safety data compilation processes with the updated MHRA guidance to ensure that all necessary information is included in clinical investigation proposals.

Sponsors in the ILAP must update their Target Development Profiles to reflect the revised TDP and coordinate closely with pharmacovigilance teams for alignment with the new roadmap.

Organizations must update their adverse event reporting processes to align with the clarified classification of borderline products effective immediately.

Implement mandatory quality checks and oversight for all AI-generated inspection responses to meet MHRA expectations for accuracy.

Stakeholders should assess the proposed changes to the fee structure and provide feedback by September 25, 2026. This includes understanding the implications of the new fee levels and service standards on their compliance efforts.

Innovators must now utilize the Innovation Accelerator for access to regulatory expertise and guidance on pharmacovigilance and risk management strategies.