In a landmark achievement for global health governance, Sri Lanka’s National Medicines Regulatory Authority (NMRA) has finalized the world’s first-ever United Nations-assisted self-assessment of corruption risks within a national regulatory authority. This pioneering initiative, jointly supported by WHO and the United Nations Office on Drugs and Crime (UNODC), marks a significant step in enhancing transparency, integrity and public trust in medical product regulation.
The process was conducted through two intensive workshops held in February and April 2025 in Colombo. It is grounded in UNODC’s internationally recognized corruption risk assessment methodology, aligned with ISO 31000 international standards for risk management and adapted for regulatory authorities with technical input from WHO.
Established in 2015, NMRA plays a central role in safeguarding public health by ensuring that medicinal products in Sri Lanka meet rigorous safety, quality and efficacy standards. Recognizing the importance of preventing and addressing corruption risks, NMRA sought WHO and UNODC support to conduct a structured, evidence-based self-assessment.
“The assisted self-assessment process has provided us with a structured, evidence-informed approach to better understand and address corruption risks in regulatory functions. This milestone reflects our continued commitment to strengthening institutional integrity, promoting good governance, and ensuring public confidence in the regulation of medical products,” said Dr Saveen Semage, NMRA’s CEO, during the workshop. “We believe this experience will contribute meaningfully to global efforts aimed at enhancing transparency and accountability in health systems.”
The NMRA assessment focused on analyzing internal regulatory functions to identify corruption risks and prioritize mitigation strategies. Participants from NMRA and external stakeholders collaborated on a final work plan that includes long-term monitoring, evaluation and communication mechanisms.
By embedding risk management into its ongoing operations, NMRA has laid the groundwork for sustained institutional reform, offering a replicable model for other national regulatory authorities worldwide. The initiative supports the Sustainable Development Goals (SDGs), particularly SDG 3 (good health and well-being) and SDG 16 (peace, justice, and strong institutions), and advances the implementation of the UN Convention against Corruption (UNCAC).
Sri Lanka’s experience reinforces the value of collaboration between national authorities and international agencies to build resilient, transparent health systems. It also contributes to WHO’s work in benchmarking and strengthening national regulatory authorities through its Global Benchmarking Tool and to combat substandard and falsified medical products.
“This process equips regulatory agencies not only to identify risks but to institutionalize integrity,” noted a joint statement from WHO and UNODC representatives. “Sri Lanka’s example is a global milestone in building resilient, transparent health systems.”
The lessons learned and best practices from this initiative provide a valuable resource for countries seeking to enhance the integrity and effectiveness of their health regulatory systems. The NMRA is committed to continual improvement, transparency, and strengthening public confidence in medical product oversight.