Updates on ISO 14155 and N=1 Therapeutics Discussed by TGA
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.
Primary source: Veterinary Medicines Directorate (VMD)
The launch of the new VMD Industry Pharmacovigilance Reporting Service effective from July 10, 2026, allows MAHs to submit safety data through a centralized digital platform, integrating multiple submission types.
This new service enhances the efficiency and user-friendliness of reporting obligations, helping MAHs comply with legislative requirements.
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.
Regulatory Intelligence Lead
Review before 2026-07-10.
Launch of the VMD Industry Pharmacovigilance Reporting Service. It supports submission of Benefit-Risk reports, signal notifications, Pharmacovigilance Sales Submissions, and XML reports. Features include submission status tracking and exportable logs. It is currently in beta but available for use.
MAHs for veterinary medicines should transition to the new digital service for submitting safety data and signal notifications. While optional during the beta phase, it is designed to replace the VMDS secure messaging service over time.
More efficient and user-friendly experience for MAHs
Integration of multiple submission types into a single platform
MAHs can choose whether to adopt new reporting system or continue with existing methods
Optional use of new digital service during beta version
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.
The VMD has introduced a new digital service that centralizes various pharmacovigilance report submissions for MAHs, including Benefit-Risk Submission Reports and signal notifications, into a single platform. This service is currently in beta and will replace the VMDS secure messaging service over time.
What changed: The launch of the new VMD Industry Pharmacovigilance Reporting Service effective from July 10, 2026, allows MAHs to submit safety data through a centralized digital platform, integrating multiple submission types.
Why it matters: This new service enhances the efficiency and user-friendliness of reporting obligations, helping MAHs comply with legislative requirements.
Practical implication: 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.
Published from the Firecrawl policy change extraction pipeline.
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.
Safety lead to: (1) perform a UK-clinical-trial safety reporting gap assessment against MHRA’s effective guidance sections (MedDRA coding; AE/SAE; RSI governance; SUSARs; annual safety reporting; USMs; serious breaches; temporary suspension), (2) update controlled SOPs/WIs and training records to reflect “effective” status as of 28 Apr 2026, and (3) document deviations/gaps and open CAPA where needed for ongoing UK trials and new submissions.
Sponsors and MAHs must review and align safety data collection and reporting protocols with the newly adopted guidelines while preparing for implementation of PRAC recommendations stemming from this meeting.
Healthcare facilities must utilize the new checklist during inspections to conduct gap analyses and ensure compliance with reporting requirements associated with their vigilance systems.