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.

Afiliação

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 em En | MEDLINE | ID: mdl-37806812

Assuntos

Antineoplásicos; Humanos; Antineoplásicos/efeitos adversos; Biomarcadores; China; Aprovação de Drogas/métodos; Estados Unidos; United States Food and Drug Administration; Ensaios Clínicos Controlados Aleatórios como Assunto

Palavras-chave

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

Texto completo

Imprimir

XML

PubMed Links

Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Antineoplásicos Tipo de estudo: Clinical_trials / Systematic_reviews Limite: Humans País/Região como assunto: America do norte / Asia Idioma: En Revista: Clin Ther Ano de publicação: 2023 Tipo de documento: Article

Texto completo

Imprimir

XML

PubMed Links

Buscar no Google