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A preliminary analysis of WHO's initiatives and tools for promoting the improvement of medical product regulatory capacity worldwide (part I): the core content of global competency framework for regulators of medicines and guidelines for advancing smart regulation
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Yan-ling ZHANG1, 2, Ming-shu MA2, Yi-fei WANG2, Rong SHAO1, *
Chinese Journal of New Drugs | 2026, 35(8) : 812 - 818
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Chinese Journal of New Drugs | 2026, 35(8): 812-818
A preliminary analysis of WHO's initiatives and tools for promoting the improvement of medical product regulatory capacity worldwide (part I): the core content of global competency framework for regulators of medicines and guidelines for advancing smart regulation
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Yan-ling ZHANG1, 2, Ming-shu MA2, Yi-fei WANG2, Rong SHAO1, *
Affiliations
  • 1School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China
  • 2Health China Research Institute, China Health Media Group, Beijing 100082, China
Published: 2026-04-30 doi: 10.20251/j.cnki.1003-3734.2026.08.004
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As a specialized agency of the United Nations, the World Health Organization (WHO) is dedicated to promoting the effective regulation of medical products across countries, ensuring that medicines, vaccines, and medical devices can sustain the normal functioning of national health systems and enable individuals from different countries to access high-quality health support. Since 2014, WHO has launched the regulatory systems strengthening (RSS) program for medical products, adopting a series of initiatives to develop a comprehensive framework that guides countries in enhancing their medical product regulatory capacities and provides crucial support for the coordinated improvement of regulatory capabilities on a global scale. This paper focuses on explaining the core initiatives under the RSS program, including the quality management system (QMS), good regulatory practices (GRP), good reliance practices (GRelP), and global competency framework (GCF), which is expected to provide references and insights to accelerate the modernization of drug administration and enhance the international competitiveness of the pharmaceutical industry in China.

WHO  /  regulatory systems strengthening  /  quality management system  /  good regulatory practices  /  good reliance practices  /  global competency framework
张燕玲, 马茗舒, 王艺霏, 邵蓉. 浅析WHO促进各国医疗产品监管水平提升的举措与工具（上）——全球药品监管能力框架与促进智慧监管指导原则的核心内容. 中国新药杂志, 2026 , 35 (8) : 812 -818 . DOI: 10.20251/j.cnki.1003-3734.2026.08.004
Yan-ling ZHANG, Ming-shu MA, Yi-fei WANG, Rong SHAO. A preliminary analysis of WHO's initiatives and tools for promoting the improvement of medical product regulatory capacity worldwide (part I): the core content of global competency framework for regulators of medicines and guidelines for advancing smart regulation[J]. Chinese Journal of New Drugs, 2026 , 35 (8) : 812 -818 . DOI: 10.20251/j.cnki.1003-3734.2026.08.004
Appendix
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Year 2026 volume 35 Issue 8
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Article Info
doi: 10.20251/j.cnki.1003-3734.2026.08.004
  • Online Date：2026-10-26
  • Published：2026-04-30
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History
  • Accepted：2026-01-12
Affiliations
    1School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China
    2Health China Research Institute, China Health Media Group, Beijing 100082, China
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小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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