Strengthening drug regulation in southeast and south Asia: A comparative analysis of DAV and NMRA

This study presents a comparative analysis of the pharmaceutical regulatory systems in Vietnam and Sri Lanka, focusing on the Drug Administration of Vietnam (DAV) and the National Medicines Regulatory Authority (NMRA) of Sri Lanka. Both agencies play critical roles in ensuring the safety, efficacy, and quality of medicines within their countries, yet they operate within distinct institutional frameworks shaped by differing historical, legal, and socio-economic contexts. Through a qualitative review of policy documents, regulatory guidelines, and academic literature, this research evaluates the organizational structures, drug approval processes, pharmacovigilance mechanisms, enforcement practices, and international collaborations of both regulatory bodies. Findings reveal that while Vietnam benefits from strong regional integration and harmonization efforts through ASEAN, Sri Lanka’s NMRA demonstrates greater administrative autonomy and focused reform initiatives. Both agencies face challenges related to limited resources, capacity constraints, and the need for enhanced post-market surveillance. The COVID-19 pandemic further highlighted their regulatory agility and areas needing improvement. This comparative study provides valuable insights for policymakers and stakeholders aiming to strengthen pharmaceutical regulation in low- and middle-income countries, emphasizing the importance of balanced governance, capacity building, and international cooperation in safeguarding public health.