Your Local Pharmacovigilance Partner for Drug Safety in Sri Lanka
DDReg provides pharmacovigilance services in Sri Lanka for pharmaceutical marketing authorisation holders. Our team operates local PV systems for foreign MAHs, manages NMRA Pharmacovigilance Division adverse event reporting, prepares Periodic Safety Update Reports, coordinates post-marketing surveillance, and delivers pharmacovigilance outsourcing Sri Lanka mandates across the full product lifecycle.
Sri Lanka Pharmacovigilance Framework
The National Medicines Regulatory Authority (NMRA) governs pharmaceutical regulation in Sri Lanka under the NMRA Act No. 5 of 2015. Within the NMRA, the Pharmacovigilance Division is responsible for monitoring and managing adverse drug reactions, quality failures, and counterfeit medicines. The division implements robust post-marketing surveillance systems to track adverse reactions, conduct quality reviews, and ensure ongoing compliance with regulatory standards throughout the product lifecycle.
NMRA collaborates with international pharmacovigilance networks including the WHO Programme for International Drug Monitoring. The Medicines Evaluation Committee (MEC) and the Safety of Medicines and Risk Evaluation Sub-Committee review safety data and recommend regulatory actions including product recalls. NMRA may recall any medicine or medical device on safety alerts issued by WHO or other National Regulatory Agencies, on the recommendation of the MEC or Safety Sub-Committee or based on reports from approved analysts under the NMRA Act.
Pharmacovigilance Outsourcing Sri Lanka - DDReg Services
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Local PV System and Adverse Event Reporting
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Drug Safety Services Sri Lanka - PSURs and Post-Marketing Surveillance
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Regulatory Compliance and Recall Coordination
Qatar Pharmacovigilance Reporting Requirements
| Obligation | Requirement | Authority |
|---|---|---|
| Adverse drug reaction reporting | Per NMRA requirements | NMRA Pharmacovigilance Division |
| PSUR (Periodic Safety Update Reports) | Per registration requirements and NMRA requests | NMRA Pharmacovigilance Division |
| Post-marketing surveillance | Continuous safety and efficacy monitoring | NMRA surveillance programmes |
| Quality failure reporting | Immediate notification to NMRA | NMRA Pharmacovigilance Division |
| Counterfeit medicine reporting | Immediate notification to NMRA | NMRA Pharmacovigilance Division |
| Product recall compliance | On MEC/Sub-Committee/WHO/NRA recommendation | NMRA under NMRA Act |
Pharmacovigilance Company in Sri Lanka - DDReg Expertise
DDReg understands the NMRA Pharmacovigilance Division operational structure and the Safety of Medicines and Risk Evaluation Sub-Committee review process. Our team manages adverse event submissions to the Pharmacovigilance Division at NMRA headquarters in Colombo, prepares safety documentation for MEC and Sub-Committee review, and coordinates product recall implementation when NMRA issues recall recommendations under the NMRA Act.
NMRA implements robust post-marketing surveillance systems that track adverse reactions and conduct quality reviews throughout the product lifecycle. DDReg integrates MAH pharmacovigilance data with NMRA surveillance programmes, coordinates with the National Medicines Quality Assurance Laboratory (NMQAL) on quality failure investigations and manages the continuous safety and efficacy monitoring obligations that extend beyond initial registration approval.
Sri Lanka participates in the WHO Programme for International Drug Monitoring. NMRA may initiate product recalls based on WHO safety alerts or alerts from other National Regulatory Agencies. DDReg monitors WHO VigiBase signals, international regulatory authority safety communications, and regional NMRA outputs for products registered in Sri Lanka ensuring MAHs are informed of international safety developments that may trigger NMRA action or require Sri Lankan product information updates.
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