Sri Lanka

Pharmacovigilance in Sri Lanka is regulated by the National Medicines Regulatory Authority (NMRA). Its official pharmacovigilance page provides the national adverse-event reporting route and publishes the current pharmacovigilance guidance set, including the Guideline on Pharmacovigilance System Master File (PSMF), the guideline on pharmacovigilance systems and their quality systems, and Guidelines for Monitoring and Reporting Adverse Drug Reactions (GL-016, Version 2.0). Marketing authorisation Holders should establish and maintain a documented pharmacovigilance system, assign qualified responsibility, keep an up-to-date PSMF, collect and evaluate suspected adverse reactions, conduct signal and benefit–risk evaluation, implement risk-minimisation measures and submit required safety information to NMRA. The applicable ICSR reporting timelines, periodic report schedule, RMP commitments and PSMF presentation should be taken from the current NMRA guideline and the product’s authorisation conditions, since requirements may vary by report type and product status. Healthcare professionals can also submit cases through the reporting channels linked by NMRA. Companies should retain evidence of compliance and remain prepared for regulatory review or inspection. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance; How to Prepare and Comply with a Pharmacovigilance Inspection.