Progress and Challenges of the New Conditional Approval Process in China: A Pooled Analysis From 2018 to 2021.

Li, Jinlian; Wang, Haoyang; Hua, Yanzhao; Liu, Yue; Chen, Yi; Jiang, Rong; Shao, Rong; Xie, Jinping

Li, Jinlian; Wang, Haoyang; Hua, Yanzhao; Liu, Yue; Chen, Yi; Jiang, Rong; Shao, Rong; Xie, Jinping.

Afiliación

Li J; Institute of Regulatory Science for Medical Products, China Pharmaceutical University, Nanjing, Jiangsu Province, China.
Wang H; Institute of Regulatory Science for Medical Products, China Pharmaceutical University, Nanjing, Jiangsu Province, China.
Hua Y; Institute of Regulatory Science for Medical Products, China Pharmaceutical University, Nanjing, Jiangsu Province, China.
Liu Y; Institute of Regulatory Science for Medical Products, China Pharmaceutical University, Nanjing, Jiangsu Province, China.
Chen Y; Institute of Regulatory Science for Medical Products, China Pharmaceutical University, Nanjing, Jiangsu Province, China.
Jiang R; Institute of Regulatory Science for Medical Products, China Pharmaceutical University, Nanjing, Jiangsu Province, China; NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation, Nanjing, Jiangsu Province, China.
Shao R; Institute of Regulatory Science for Medical Products, China Pharmaceutical University, Nanjing, Jiangsu Province, China; NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation, Nanjing, Jiangsu Province, China.
Xie J; Institute of Regulatory Science for Medical Products, China Pharmaceutical University, Nanjing, Jiangsu Province, China; NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation, Nanjing, Jiangsu Province, China. Electronic address: 1620214654@cpu.edu.cn.

Clin Ther ; 45(11): 1111-1118, 2023 11.

Article en En | MEDLINE | ID: mdl-37806812

Asunto(s)

Antineoplásicos; Humanos; Antineoplásicos/efectos adversos; Biomarcadores; China; Aprobación de Drogas/métodos; Estados Unidos; United States Food and Drug Administration; Ensayos Clínicos Controlados Aleatorios como Asunto

Palabras clave

Center for Drug Evaluation; Conditional approval process; National Medical Products Administration; New drug registration and review

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antineoplásicos Tipo de estudio: Clinical_trials / Systematic_reviews Límite: Humans País/Región como asunto: America do norte / Asia Idioma: En Revista: Clin Ther Año: 2023 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos

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