Regulatory intelligence in PV

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.

Organizations involved in medical device compliance should prepare for potential future changes requiring MHRA-issued licenses for devices entering the market.

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.

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.

Stakeholders can submit NAMs data by completing the prescribed application form, available until Q3 2027.

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