Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Marketing authorisation holders should prepare to update their COVID-19 vaccines to target the XFG variant for the upcoming campaign; monitor for further regulatory guidance and prepare for potential strain change submissions.

1) Add/confirm the TGA 'medical device post-market monitoring and safety updates' page as a tracked regulatory intelligence source for routine review. 2) Cross-check internal Australia device vigilance SOPs/work instructions against TGA guidance on sponsor/manufacturer post-market responsibilities and document any gaps for CAPA/change control as needed.

Pharmaceutical companies should prepare to assess the impact of hepatic impairment early in drug development, particularly for drugs that require pharmacokinetic assessments.

Update internal systems and workflows to integrate monthly Excel reports from EMA starting March 2025, ensuring timely capture of information on medicines under evaluation and any extension applications.

Regulatory Intelligence leads should initiate monitoring of feedback and prepare for potential regulatory adjustments related to the specified substances.

Small business dispensers are encouraged to complete a mandatory assessment survey by September 22, 2026, and do not need to submit information to the FDA while utilizing these exemptions.

Stakeholders are advised to submit comments on the draft guidance by 11/18/2026, using docket number FDA-2026-D-8561 to ensure FDA considers their feedback before finalizing the document.

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