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: Health Sciences Authority
New mandatory safety reporting and record-keeping requirements for suppliers of Complementary Health Products (CHPs) in Singapore are proposed under the Health Products Act.
These requirements will strengthen the oversight of CHP products, ensuring better safety and quality standards which could impact compliance workflows for suppliers.
Suppliers must implement new protocols for safety reporting and record-keeping as per the proposed framework.
Regulatory Intelligence Lead
Review before 2026-07-29.
Proposed requirements for Product Notification, Record Keeping, and Safety Reporting for CHPs.
Suppliers of CHPs in Singapore may face new mandatory safety reporting and record-keeping requirements under the proposed framework.
Suppliers must implement new protocols for safety reporting and record-keeping as per the proposed framework.
The Health Sciences Authority (HSA) of Singapore has opened a consultation on a proposed regulatory framework aimed at enhancing the safety and quality oversight of Complementary Health Products (CHP). This includes new mandatory requirements for Product Notification, Record Keeping, and Safety Reporting. The deadline for feedback is July 29, 2026.
What changed: New mandatory safety reporting and record-keeping requirements for suppliers of Complementary Health Products (CHPs) in Singapore are proposed under the Health Products Act.
Why it matters: These requirements will strengthen the oversight of CHP products, ensuring better safety and quality standards which could impact compliance workflows for suppliers.
Practical implication: Suppliers must implement new protocols for safety reporting and record-keeping as per the proposed framework.
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.