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Discussion on provisions of Drug Administration Law on Chinese herbal pieces not conforming to drug standards without affecting safety and effectiveness
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Yun LIANG1, Xin-yue LI2, Sai-nan LUO3, Rong JIANG2
Chinese Journal of New Drugs and Clinical Remedies | 2024, 43(1) : 29 - 34
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Chinese Journal of New Drugs and Clinical Remedies | 2024, 43(1): 29-34
• Policy and Management •
Discussion on provisions of Drug Administration Law on Chinese herbal pieces not conforming to drug standards without affecting safety and effectiveness
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Yun LIANG1, Xin-yue LI2, Sai-nan LUO3, Rong JIANG2
Affiliations
  • 1.Guangdong Medical Products Administration, Guangzhou GUANGDONG, 510080, China
  • 2.Institute of Regulatory Science, China Pharmaceutical University, Nanjing JIANGSU 211198, China
  • 3.Guangdong Food and Drug Vocational College, Guangzhou GUANGDONG 510520, China
Published: 2024-01-25 doi: 10.14109/j.cnki.xyylc.2024.01.06
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Considering the special characteristics of traditional Chinese herbal pieces, Article 117 (2) of the Drug Administration Law provides special provisions for situations where traditional Chinese herbal pieces do not meet the standards and do not yet affect the safety and efficacy. This article will focus on the development of guidance documents related to Article 117 (2) of the Drug Administration Law, surrounding the applicable circumstances of non-compliance with drug standards for traditional Chinese herbal pieces that do not yet affect safety and efficacy, risk assessment and enterprise recall provisions, in conjunction with the provisions of the penalty basis to analysis and discuss judicial cases of administrative penalties, so as to provide reference for strict standardized law enforcement and promote uniform law enforcement.

Chinese materia medica preparation  /  herbal pieces for decoction  /  safety  /  treatment outcome  /  Drug Administration Law
Yun LIANG, Xin-yue LI, Sai-nan LUO, Rong JIANG. Discussion on provisions of Drug Administration Law on Chinese herbal pieces not conforming to drug standards without affecting safety and effectiveness[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024 , 43 (1) : 29 -34 . DOI: 10.14109/j.cnki.xyylc.2024.01.06
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Year 2024 volume 43 Issue 1
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Article Info
doi: 10.14109/j.cnki.xyylc.2024.01.06
  • Receive Date：2023-06-19
  • Online Date：2026-03-19
  • Published：2024-01-25
Article Data
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History
  • Received：2023-06-19
  • Accepted：2023-09-18
Affiliations
    1.Guangdong Medical Products Administration, Guangzhou GUANGDONG, 510080, China
    2.Institute of Regulatory Science, China Pharmaceutical University, Nanjing JIANGSU 211198, China
    3.Guangdong Food and Drug Vocational College, Guangzhou GUANGDONG 510520, China
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https://castjournals.cast.org.cn/joweb/zgxyylczz/EN/10.14109/j.cnki.xyylc.2024.01.06
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表12种不同金属材料的力学参数
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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