Considerations on Clinical Development and Regulatory of the Oversea License-in
Anti-tumor Drugs.
10.3779/j.issn.1009-3419.2022.101.27
- Author:
Xiao ZHAO
1
;
Ruimin HAO
1
;
Xin TONG
1
;
Limin ZOU
1
;
Ling TANG
1
;
Hong ZHANG
1
;
Lin XIA
1
;
Zhimin YANG
1
Author Information
1. Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China.
- Publication Type:Journal Article
- Keywords:
Anti-tumor drug;
Bridging study;
License-in;
Research and development strategy
- MeSH:
Antineoplastic Agents/therapeutic use*;
China;
Drug Industry;
Humans;
Lung Neoplasms/drug therapy*;
Pharmaceutical Preparations
- From:
Chinese Journal of Lung Cancer
2022;25(7):448-451
- CountryChina
- Language:Chinese
-
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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