Regulatory Intelligence Lead

Sponsors must prepare for increased costs tied to the submission and maintenance of products on the ARTG which will impact their regulatory budget planning and compliance processes.

MAHs should prepare for enhanced regulatory collaboration, including potential joint oversight activities and reduced market friction between the UK and US due to closer alignment in regulatory decisions.

Review and implement the TGA checklist for all psychiatrist prescribers of MDMA/psilocybine; update ICSR workflows to capture adverse events as per checklist requirements.

Update internal labeling workflows to align with the revised checklist; ensure submission documents meet updated formatting requirements for linguistic review.

Review the consultation document and consider submitting feedback by 2026-07-31. Monitor for final regulatory changes affecting radiopharmaceutical safety monitoring and compliance.

Review the PSUSA documents for calcifediol and ensure alignment with any PRAC recommendations if applicable.

Check stock for the affected batches of Ponlimsi (Denosumab) 60mg solution for injection and follow the instructions in the MHRA notice.

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.

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

Stakeholders, including those involved in labeling and signal management, should consider the published comments to align future processes with the regulatory expectations detailed in the draft ICH E22 guideline.

MAHs should review the updated DRGD to understand new processing timelines for variation submissions and assess how the reliance mechanism can be leveraged for faster safety updates. Adjust internal timelines and processes for post-marketing variation submissions accordingly.

Review updated PMDE Program procedures on CDA-AMC website and assess impact on current post-market surveillance activities in Canada.