Effective

Manufacturers must evaluate their products against the new thresholds and update their risk management plans (RMPs) and risk-based monitoring protocols if any exceed the limits.

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.

Update electronic safety reporting systems and pharmacovigilance databases to implement new rules to ensure all submissions use GENC 3-letter country codes and include the required fields as of July 20, 2026.

Clinical trial sponsors must update their internal SOPs for safety reporting and ensure staff are trained on the new submission steps for ASRs through the CTIS platform.

MAHs are encouraged to transition to the new digital service for all pharmacovigilance reporting and utilize the feedback function during the beta phase to improve the service.

Healthcare providers must ensure patient registrations and comply with adverse event reporting as per the renewed compassionate use framework, which includes the collection and analysis of safety data.

Manufacturers must implement processes for device registration in swissdamed before placing devices on the market, with immediate attention needed for vigilance-reportable incidents.

Ensure all relevant teams are prepared to transition to the mandatory SEND format for data submissions by the effective date of 15 June 2026.

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.

Healthcare facilities must utilize the new checklist during inspections to conduct gap analyses and ensure compliance with reporting requirements associated with their vigilance systems.

Manufacturers must demonstrate that any variances from the foreign authorized drugs do not adversely affect safety or effectiveness when filing for deeming under this new framework.

CTIS users are now required to actively monitor notifications daily to ensure timely awareness of safety-related tasks.

Implement mandatory quality checks and oversight for all AI-generated inspection responses to meet MHRA expectations for accuracy.

MAHs must update their application submission procedures to utilize the SUGAM portal for all relevant post-approval changes from June 24, 2026.

MAHs must implement safety monitoring protocols and ensure compliance with reporting obligations associated with the newly classified prescription drugs.