Companies must implement a strategy to upgrade from Windows 10 to Windows 11 and ensure compliance with essential safety principles, including notifying customers about potential vulnerabilities.
Entities affected by this notification must review their plasma product lot processes and ensure compliance with NPRA regulations. Affected stakeholders should adjust workflows to address non-compliance issues.
Implement an immediate review of affected vaccine lots and ensure all relevant stakeholders are informed of the compliance issues for Signal Management processes.
Organizations must increase scrutiny and evaluation of vaccine safety profiles for lots identified in the notification of non-compliance.
MAHs and sponsors of priority medicines must review the updated PRIME guidance to ensure compliance with new interaction expectations, particularly regarding risk management planning and post-authorisation safety monitoring.
Stakeholders must prepare for changes in how early-phase safety data is reported and engage in the continuous safety dialogue encouraged by the FDA. Ensure timely submission of comments by July 22, 2026.
MAHs and SMEs must review the updated fee structures and assess the potential for fee reductions on safety-related submissions to align with the new regulatory framework.
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.
