MHRA

MAHs and sponsors must enhance their pharmacovigilance systems to monitor microbiome-specific safety issues, comply with established safety standards, and address concerns related to antimicrobial resistance.

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.

PV and device vigilance teams need to review their AVT product portfolios to verify correct classification and ensure adherence to medical device vigilance reporting workflows, especially for those tools classified as medical devices.

Safety lead to: (1) perform a UK-clinical-trial safety reporting gap assessment against MHRA’s effective guidance sections (MedDRA coding; AE/SAE; RSI governance; SUSARs; annual safety reporting; USMs; serious breaches; temporary suspension), (2) update controlled SOPs/WIs and training records to reflect “effective” status as of 28 Apr 2026, and (3) document deviations/gaps and open CAPA where needed for ongoing UK trials and new submissions.

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.

Identify and quarantine all impacted batches of ChloraPrep 2% 1mL and Frepp 2% 1.5mL applicators; return to Becton Dickinson UK Ltd.

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

1) Map portfolio to MHRA’s Category 1 vs Category 2/NI MA status referenced in the Windsor Framework PV guidance; 2) Update PSUR submission SOPs/work-instructions and submission trackers to ensure Category 1 PSURs route via the MHRA PSUR portal and Category 2/NI MA PSURs route via the EU PSUR Repository (and confirm when no separate MHRA submission is needed); 3) Re-check related MHRA PV procedure guidance for any additional submission/documentation expectations impacting signals, RMPs and PASS.

Safety/Device Vigilance owner to: (1) confirm SOPs and training link to MHRA’s “Medical devices: post-market surveillance” collection as the live index; (2) validate operational readiness to submit adverse incident and FSCA-related reports via MHRA’s referenced MORE route; (3) confirm device PSUR process uses MHRA-linked standardised PSUR format and PSUR guidance tied to the Regulations 2024 framework; (4) update internal regulatory intelligence trackers with the 16 June 2025 in-force date cited across MHRA guidance, and monitor related MHRA future regime pages for further updates.

Mhra update requires triage for Signal Validation, Risk Management, Local Affiliate Compliance; confirm local obligations and document follow-up actions.

Update local protocols to ensure parenteral nutrition is administered with filters in compliance with the new requirements.

Healthcare professionals should not initiate treatment with Avacopan Vifor for new patients and must review existing patients' treatment plans to ensure safe transitions to alternative therapies.

Monitor and evaluate the drug misuse trends and health impacts associated with ketamine, focusing on the increase in seizures as part of public health and law enforcement strategies.

Healthcare providers must implement a follow-up process for patients with identified cobalt-chrome modular neck components, monitoring for new or unexpected symptoms including pain, stiffness, or instability.

Organisations should review their DBS checking arrangements, especially prioritizing checks that include the Children's Barred List for those working with children, as part of their compliance with the new definition from September 2026.

Submit bluetongue samples to APHA with forms attached securely on the outside of the parcel to facilitate rapid booking into their digital sample handling system.

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.