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System Analysis of Pediatric Regulation in the European Union
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Xiuli LI, Dan LI, Liping QU*, Tingmo ZHANG, Dingkun ZHANG, Shiyu WANG*
Chinese Pharmaceutical Journal | 2024, 59(12) : 1165 - 1170
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Chinese Pharmaceutical Journal | 2024, 59(12): 1165-1170
System Analysis of Pediatric Regulation in the European Union
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Xiuli LI, Dan LI, Liping QU*, Tingmo ZHANG, Dingkun ZHANG, Shiyu WANG*
Affiliations
  • School of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu 611137, China
Published: 2024-06-22 doi: 10.11669/cpj.2024.12.014
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OBJECTIVE To analyze the key contents of paediatric regulation in the European Union (EU) and identify the characteristics of the European regulation for paediatric medicines. METHODS A literature review was conducted to analyze the EU paediatric regulation, relevant guidance documents and published literatures. RESULTS The EU has established the paediatric medicines committee, which is specifically responsible for issues related to the regulation of paediatric medicines. Moreover, the EU has systematically designed the regulation around four aspects including obligations, rewards and incentives, other initiatives for paediatric medicines research and information and transparency measures. CONCLUSION The EU attaches great importance to building a professional team for the regulation of paediatric medicines, focusing on both mandatory and incentives, and emphasizing the concepts of the whole life cycle of medicines and dynamic adjustments, which provide a comprehensive guarantee for promoting the development and availability of paediatric medicines. It deserves to be studied and learned from.

pediatric medicine  /  regulation  /  mandatory obligation  /  rewards  /  incentive  /  life cycle
Xiuli LI, Dan LI, Liping QU, Tingmo ZHANG, Dingkun ZHANG, Shiyu WANG. System Analysis of Pediatric Regulation in the European Union[J]. Chinese Pharmaceutical Journal, 2024 , 59 (12) : 1165 -1170 . DOI: 10.11669/cpj.2024.12.014
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doi: 10.11669/cpj.2024.12.014
  • Receive Date：2023-03-07
  • Online Date：2025-11-25
  • Published：2024-06-22
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  • Received：2023-03-07
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    School of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu 611137, 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
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Genus		 种数
Number of
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Percentage of total
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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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