Strong Regulation of Medical Products: Cornerstone of Public Health and Regional Health Security

National regulatory agencies (NRAs) are the gatekeepers of the supply chain of medical products such as pharmaceuticals and medical devices. It is through registration with an NRA that a manufacturer brings products to market. Post-marketing surveillance of how those products perform and impact patient safety—including how quality is maintained in storage and distribution, and adverse events associated with their use—also falls under the agency’s remit, as does inspection of manufacturing facilities and regulation of product promotion and advertising. At the same time, the value chain for medical products is becoming increasingly globalized.

Disease control and prevention, already a challenging task in resource-constrained environments, is adversely affected by weak regulation. For example, in Asia and the Pacific as a whole, and the Greater Mekong Subregion (GMS) in particular, NRAs are not yet well equipped to support the elimination of malaria, a goal that governments across the region are committed to achieving by 2030. Unregulated medicines in the supply chain, including fake and substandard medicines, are fueling resistance to artemisinin combination therapies, the key and most effective treatment for malaria. This is undermining the region’s drive to achieve elimination of malaria as a public health threat by 2030.

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