Full
Outline
To reveal the evolution trend of the objectives of policies related to the subject responsibility for drug quality and safety in China and the possible deficiencies through a quantitative analysis of policy texts, thereby providing a basis for optimizing the drug regulatory system and promoting the implementation of the subject responsibility.
This study mainly employed text mining and co-word analysis method, through utilizing ROSTCM6 software to perform word segmentation, word frequency statistics, and semantic network analysis on 37 policy documents issued at the national level between 2012 and 2025, to explore the distribution patterns of high-frequency thematic words and the characteristics of policy evolution.
The study found that the policies present characteristics of "phased evolution”: the subject words gradually transform from "quality" and "enterprise" in the initial stage to "holder" and "management", the semantic network structure has changed from loose to tight, and the focus of supervision is shifting from the "responsible subject" to the dual-track mechanism of "centralization of the responsible subject and refinement of the subject responsibility”.
China has gradually established a responsibility system covering the entire life cycle of drugs, but it still needs to further refine the definition of responsibilities and strengthen quality management.
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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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