Guideline

Manufacturers and applicants must utilize the finalized scoring system for new study submissions and ensure post-market safety reports include monitoring for adhesion-related issues as indicators of product quality.

MAHs are required to ensure their safety database systems are configured to the updated E2B(R3) specifications and verify B2B gateway connections before the August 2026 deadline.

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.

MAHs must update labelling components to meet new criteria, including a minimum font size of 7 points and essential information requirements regarding the medicine's name, strength, route of administration, posology, warnings, and indications as per the guidance. New packaging must be incorporated into stocked products within six months of approval.

MAHs must categorize their proposed label and PIL updates, utilizing the self-certification route for those not requiring full assessment; submissions validated through this route will receive acceptance letters within 14 days.

Ensure all patient implant cards are updated to include full UDI information in the mandated formats by the specified timeline to comply with TGA regulations.

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.

Marketing authorisation holders must update Product Information (SPC and PL) in accordance with CVMP monthly recommendations, and ensure local affiliates are informed of new safety instructions.

Clinical safety and pharmacovigilance teams must implement new safety monitoring protocols and ensure adequate assessment of abuse potential as stipulated in the guidance.

Sponsors must adhere to defined meeting types (Type X, Y, Z) and submit meeting packages at least 3 months before planned submissions for OTC monograph drugs, ensuring FDA engagement occurs within set timelines.