Singapore's Health Sciences Authority (HSA) publishes detailed post-market safety monitoring and adverse-event reporting requirements for therapeutic products.
Core official resources
- Adverse event reporting of therapeutic products — company reporting requirements, reportability criteria, timelines and submission routes.
- Post-market surveillance, safety monitoring and advertisement — broader post-market surveillance hub, including risk-management obligations.
- Report adverse events — reporting entry point and information on the HSA adverse-event online database.
- Adverse events reporting in clinical trials — local clinical-trial safety reporting requirements.
Practical use
HSA distinguishes company obligations from healthcare-professional and consumer reporting routes. Use the company-specific therapeutic-product guidance when designing MAH or registrant procedures.