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Outline
The WHO launched the regulatory system strengthening program for medical products in 2014, aiming to encourage the enhancement of medical product regulatory levels in countries and promote the coordinated development of regulatory capabilities globally. This initiative encompasses guidelines on quality management systems, good regulatory practices, good trust practices, and a global regulatory capacity framework. Its core tools are the global benchmarking tool (GBT) for regulatory system assessment and the WHO-listed authorities (WLA) framework built upon the GBT. Understanding the assessment requirements of the GBT and WLA can not only provide ideas for improving China's drug regulatory system but also serve as a reference for aligning regulatory work with international standards. This paper systematically introduces the assessment dimensions and key requirements of the GBT and WLA in order to explore their intrinsic relationship with relevant guiding principles.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 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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