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Research on strategies of emergency post-approval changes of innovative bio-products
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Xiao QIU1, Zhen SUN1, 2, Jun HU3
Chinese Journal of New Drugs and Clinical Remedies | 2025, 44(4) : 241 - 245
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Chinese Journal of New Drugs and Clinical Remedies | 2025, 44(4): 241-245
• Policy and Management •
Research on strategies of emergency post-approval changes of innovative bio-products
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Xiao QIU1, Zhen SUN1, 2, Jun HU3
Affiliations
  • 1. Shanghai Institute of Food and Drug Control, SHANGHAI 201203, China
  • 2. Shanghai Quality Inspection and Testing Center for Innovative Biological Products, SHANGHAI 201203, China
  • 3. Shanghai Drug and Medical Device Adverse Reaction Monitoring Center, SHANGHAI 200040, China
Published: 2025-04-25 doi: 10.14109/j.cnki.xyylc.2025.04.01
Outline
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Innovative biologics are the most powerful tools for preventing and treating infectious diseases. During the containment of major public health emergencies, ensuring the production and supply of clinically urgent medications through post-approval changes carries dual requirements of compliance and urgency. This study was conducted from the perspective of enhancing prevention and control of public health emergencies. The needs and difficulties of emergency changes were analyzed, with a focus on how marketing authorization holders can efficiently carry out emergency changes to expand production capacity and accelerate release testing. Based on the analysis, relevant recommendations were proposed, such as conducting pre-research on changes, building “dual-use for routine and emergency” capabilities, implementing graded and categorized management, optimizing registration testing, and promoting the rapid microbiological methods and AI.

emergency public health event  /  biological product  /  change  /  production capacity  /  emergency support
Xiao QIU, Zhen SUN, Jun HU. Research on strategies of emergency post-approval changes of innovative bio-products[J]. Chinese Journal of New Drugs and Clinical Remedies, 2025 , 44 (4) : 241 -245 . DOI: 10.14109/j.cnki.xyylc.2025.04.01
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Year 2025 volume 44 Issue 4
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Article Info
doi: 10.14109/j.cnki.xyylc.2025.04.01
  • Receive Date：2025-01-09
  • Online Date：2025-12-15
  • Published：2025-04-25
Article Data
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History
  • Received：2025-01-09
  • Accepted：2025-02-27
Funding
Affiliations
    1. Shanghai Institute of Food and Drug Control, SHANGHAI 201203, China
    2. Shanghai Quality Inspection and Testing Center for Innovative Biological Products, SHANGHAI 201203, China
    3. Shanghai Drug and Medical Device Adverse Reaction Monitoring Center, SHANGHAI 200040, China
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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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