Sri Lanka's National Medicines Regulatory Authority (NMRA) maintains the national pharmacovigilance framework for medicines and related products.
Core official resources
- Pharmacovigilance — national ADR monitoring, reporting and guidance links.
- Report adverse events — current online reporting form.
- NMRA guidelines — includes the Pharmacovigilance System Master File guideline and pharmacovigilance-system/quality-system guidance.
Important national distinction
The NMRA publishes explicit national PSMF and pharmacovigilance quality-system guidance in addition to spontaneous-reporting material. These documents should therefore be reviewed directly when designing a Sri Lankan company PV system rather than assuming that another jurisdiction's PSMF structure automatically applies.