Notice

Investigators need to modify trial protocols and safety reporting mechanisms in line with the latest ISO 14155 updates to ensure compliance for upcoming high-risk clinical trials.

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.

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

MAHs must ensure new medicinal product information texts use updated templates by 1 July 2026 and revise existing texts at the earliest opportunity if they include instructions for use.

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

Clinical trial sponsors must update internal standard operating procedures (SOPs), conduct staff training on the functionality of the new ASR module, and utilize the CTIS training environment to ensure readiness for compliance with the new workflow.

Stakeholders are encouraged to utilize the provided e-learning modules to improve their inspection readiness and compliance with GCP standards in Australia.

Incorporate enhanced requirements for monitoring pregnancy-specific safety signals into existing pharmacovigilance practices.

MAHs and trial sponsors must align their safety monitoring and data collection workflows with the new GCP principles established in ICH E6(R3) Annex 2.

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

Sponsors must align their products with the updated safety and formulation requirements for permissible ingredients as per the new determination.

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.