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Research on the current regulatory status of FDA on complex generic drugs
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Yu SUN1, Gan XU2, Qi WANG3
Chinese Journal of New Drugs | 2021, 30(6) : 496 - 500
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Chinese Journal of New Drugs | 2021, 30(6): 496-500
Research on the current regulatory status of FDA on complex generic drugs
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Yu SUN1, Gan XU2, Qi WANG3
Affiliations
  • 1Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
  • 2Beijing University of Chinese Medicine, Beijing 102248, China
  • 3National Institutes for Food and Drug Control, Beijing 100050, China
Published: 2021-03-30
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This article analyzed the current regulatory situation of FDA on complex generic drugs (nonbiological complex drugs) from two aspects: First, the feasibility of technical evaluation of pharmaceutical equivalence and bioequivalence of complex generic drugs; second, FDA's response strategy to the doubts and challenges of complex generic drugs. The complex generic drugs defined by the FDA contain natural-sourced complex drug substances. The article summarized the FDA's measures using regulatory science to vigorously promote scientific research when facing scientific challenges of complex generic drugs. The methods of promotion include formulating scientific research plans, identifying key research areas, setting up topics, summarizing annual scientific research results, and strengthening communication with the industry. The thoughts of FDA on complex generic drugs may be used as a reference for the technical evaluation of traditional Chinese medicines with the same name and same prescription.

complex generic drug  /  nonbiological complex drug  /  pharmaceutical equivalence (PE)  /  bioequivalence (BE)  /  regulatory science
孙昱, 徐敢, 汪祺. FDA复杂仿制药的监管现状研究. 中国新药杂志, 2021 , 30 (6) : 496 -500 .
Yu SUN, Gan XU, Qi WANG. Research on the current regulatory status of FDA on complex generic drugs[J]. Chinese Journal of New Drugs, 2021 , 30 (6) : 496 -500 .
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Year 2021 volume 30 Issue 6
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  • Online Date：2026-10-29
  • Published：2021-03-30
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  • Accepted：2020-10-20
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Affiliations
    1Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
    2Beijing University of Chinese Medicine, Beijing 102248, China
    3National Institutes for Food and Drug Control, Beijing 100050, China
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