Considerations on Clinical Development and Regulatory of the Oversea License-in
Anti-tumor Drugs / 中国肺癌杂志
Chinese Journal of Lung Cancer
;
(12): 448-451, 2022.
Artigo
em Chinês
| WPRIM
| ID: wpr-939730
ABSTRACT
With the boom of China's innovative pharmaceutical industry, licensing-in model has gradually become an important research and development model for innovative pharmaceutical companies. The in-licensed drugs at different stages need different research and development (R&D) strategy in China. The pharmaceutical companies take the responsibility to comprehensively collate the oversea clinical data and conduct a detailed analysis of clinical pharmacology, safety, efficacy and ethnic sensitivity. Clinical R&D strategy should be made based on the results of the above data and analysis. We encourage high-quality drugs which fill unmet clinical needs licensed in, and as early as possible, so as to conduct multi-regional clinical trials (MRCTs). The clinical R&D strategy in China is particularly important for the drug's approval. Guidelines published by the National Medical Products Administration (NMPA) and clinical associations should be followed. Communications about clinical R&D strategy with Center of Drug Evaluation (CDE) are encouraged.
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Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Preparações Farmacêuticas
/
China
/
Indústria Farmacêutica
/
Neoplasias Pulmonares
/
Antineoplásicos
Tipo de estudo:
Guia de Prática Clínica
Limite:
Humanos
País/Região como assunto:
Ásia
Idioma:
Chinês
Revista:
Chinese Journal of Lung Cancer
Ano de publicação:
2022
Tipo de documento:
Artigo
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