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The analysis of post-marketing re-evaluation system of new drugs in Japan and the enlightenment to China
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Yu-tong XUE, Guo-shu JIA, Yi LIANG
Chinese Journal of New Drugs | 2023, 32(16) : 1608 - 1614
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Chinese Journal of New Drugs | 2023, 32(16): 1608-1614
The analysis of post-marketing re-evaluation system of new drugs in Japan and the enlightenment to China
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Yu-tong XUE, Guo-shu JIA, Yi LIANG
Affiliations
  • School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China
Published: 2023-08-30
Outline
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Drug re-evaluation system has been developed in some developed countries for many years. In these countries, unique and mature drug re-evaluation systems have been established to make up for the insufficiency of pre-market research and review and further improve the safety and effectiveness of drugs. The importance of drug re-evaluation has been repeatedly verified in the practice of developed countries. China is establishing a pharmacovigilance system and should take advantage of the situation to establish a drug re-evaluation system adapted to China's national conditions, maintain focus on the safety of drugs throughout the life cycle, and ensure the medication safety of Chinese people. The post-marketing re-evaluation system in Japan has been developed for more than 40 years, and it is full of reference. This paper reviews the historical origin of Japan's post-marketing re-evaluation system, systematically analyzes Japan's post-marketing re-evaluation system from the aspects of object and period, change of laws and regulations, responsible subjects, and implementation procedures and so on. In the last part, practical suggestions are put forward for the construction of China's drug re-evaluation system.

drug re-evaluation  /  pharmaceutical policy  /  post-marketing review of new drugs in Japan  /  post-marketing management
Yu-tong XUE, Guo-shu JIA, Yi LIANG. The analysis of post-marketing re-evaluation system of new drugs in Japan and the enlightenment to China[J]. Chinese Journal of New Drugs, 2023 , 32 (16) : 1608 -1614 .
Year 2023 volume 32 Issue 16
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  • Online Date:2026-03-05
  • Published:2023-08-30
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  • Accepted:2023-03-27
Affiliations
    School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, 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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