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Regulately challenges in filing management of drug clinical trial institutions from perspective of administrative law
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Xiu-li LI1, Jian-lin XIE1, Chen-xi HU2
Chinese Journal of New Drugs and Clinical Remedies | 2024, 43(9) : 661 - 665
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Chinese Journal of New Drugs and Clinical Remedies | 2024, 43(9): 661-665
Policy and Management
Regulately challenges in filing management of drug clinical trial institutions from perspective of administrative law
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Xiu-li LI1, Jian-lin XIE1, Chen-xi HU2
Affiliations
  • 1.Center for Food and Drug Inspection of National Medical Products Administration, BEIJING 100076, China
  • 2.Center for Inspection of Jiangsu Medical Products Administration, Nanjing JIANGSU 210009, China
Published: 2024-09-25 doi: 10.14109/j.cnki.xyylc.2024.09.05
Outline
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To explore the daily regulatory strategies of regulatory authorities after the implement of filing system of drug clinical trial institutions. From the perspective of administrative law, this article analyzes the differences between the qualification recognition and filing management of drug clinical trial institutions, as well as the characteristics of filing management, and explore the adjustments and response measures for regulatory authorities of drug clinical trial institutions under the current filing system through practice. The filing system simplifies the time limit for drug clinical trial institutions to obtain qualifications, refines the admission standards for drug clinical trial institutions, highlights the qualification requirements and main responsibilities of institutions and researchers, and puts forward higher requirements for post-supervision. The update of regulatory requirements and the increase in regulatory quantity require regulatory authorities to strictly inspect standards, transform law enforcement concepts, innovate regulatory methods, strengthen risk control, and continuously improve regulatory levels, thereby to help China build high-quality drug clinical trial institutions.

drug clinical trial institutions  /  filing  /  administrative law  /  supervision
Xiu-li LI, Jian-lin XIE, Chen-xi HU. Regulately challenges in filing management of drug clinical trial institutions from perspective of administrative law[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024 , 43 (9) : 661 -665 . DOI: 10.14109/j.cnki.xyylc.2024.09.05
Year 2024 volume 43 Issue 9
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Article Info
doi: 10.14109/j.cnki.xyylc.2024.09.05
  • Receive Date:2023-11-22
  • Online Date:2026-03-18
  • Published:2024-09-25
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History
  • Received:2023-11-22
  • Accepted:2024-02-29
Affiliations
    1.Center for Food and Drug Inspection of National Medical Products Administration, BEIJING 100076, China
    2.Center for Inspection of Jiangsu Medical Products Administration, Nanjing JIANGSU 210009, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

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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