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The Impact of Regulatory Reforms in China on Drug Lag: The Role of Clinical Development Strategies.
Han, Yue; Jiang, Rong; Li, Jinlian; Wang, Yifei; Shao, Rong; Xie, Jinping.
Afiliación
  • Han Y; Institute of Regulatory Science for Medical Products, China Pharmaceutical University, Nanjing, China.
  • Jiang R; NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation, China Pharmaceutical University, Nanjing, China.
  • Li J; Institute of Regulatory Science for Medical Products, China Pharmaceutical University, Nanjing, China.
  • Wang Y; NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation, China Pharmaceutical University, Nanjing, China.
  • Shao R; Institute of Regulatory Science for Medical Products, China Pharmaceutical University, Nanjing, China.
  • Xie J; NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation, China Pharmaceutical University, Nanjing, China.
Clin Pharmacol Ther ; 115(6): 1400-1407, 2024 Jun.
Article en En | MEDLINE | ID: mdl-38429944
ABSTRACT
In recent years, there has been significant focus on China's new drug lag, but relevant research is limited. This study explores the reasons for drug lag by assessing the impact of reforms in China's drug review system, particularly focusing on the influence of clinical development strategies. This study selected drugs first launched in the United States between 2017 and 2022, examining absolute and relative lag between China and the first-launch country (including submission and review lag). These delays with drugs approved in the European Union and Japan during the same period were compared with uncover the roots of delays in China, further identifying potential factors that could reduce these delays. The results indicate that the National Medical Products Administration (NMPA) has a longer relative lag compared with the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA). The submission lag time of the NMPA significantly surpasses that of the EMA and PMDA, whereas the review lag time of the NMPA exceeds that of the PMDA but falls short of the EMA. Focusing on clinical trial strategies, bridging trials and multiregional clinical trials (MRCTs) are typically required by the NMPA in East Asia, resulting in longer clinical delay time. Whereas the EMA and PMDA primarily require international MRCTs in Europe and America, with a clinical delay of < 5 months. It is evident that there is a significant gap in clinical trial durations between China and other countries. Further optimization of clinical trial management is necessary to address the lag for new drugs in China.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Aprobación de Drogas / Desarrollo de Medicamentos Límite: Humans País/Región como asunto: America do norte / Asia Idioma: En Revista: Clin Pharmacol Ther Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Aprobación de Drogas / Desarrollo de Medicamentos Límite: Humans País/Región como asunto: America do norte / Asia Idioma: En Revista: Clin Pharmacol Ther Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos