资源环境科技发展态势分析平台

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.

Key Points

• Effective regulation and governance of the pharmaceutical sector is key to effective delivery of healthcare. In the Greater Mekong Subregion (GMS), substandard or falsified medicines detected in the supply chain are fueling resistance to artemisinin combination therapies, the most effective treatment for falciparum malaria. This resistance is undermining the region’s drive to eliminate malaria as a public health threat by 2030.
• National regulatory agencies (NRAs), who are the gatekeepers of the medical product supply chain, lack the resources needed for effective regulation within their respective jurisdictions.
• International collaboration and the implementation of common standards and activities will help the NRAs increase their capacity and improve regulatory effectiveness, leading to better public health outcomes.
• The Asian Development Bank (ADB) engaged the Centre of Regulatory Excellence (CoRE) at the Duke–National University of Singapore Medical School to assess the capacity gaps in the GMS NRAs. To address the identified needs, CoRE worked with GMS NRAs to develop national capacity development plans and, by comparison of needs, the regional road map for regulatory systems strengthening in the GMS.
• To foster ongoing regional collaboration, the Asia Pacific Regional Regulatory Partnership for Malaria Elimination (RRPME) has been established in partnership with ADB, to engage regulatory stakeholders and technical partners to support coordination of regulatory strengthening activities.