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.
Article
in Zh
| WPRIM
| ID: wpr-939730
Responsible library:
WPRO
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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Key words
Full text:
1
Index:
WPRIM
Main subject:
Pharmaceutical Preparations
/
China
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Drug Industry
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Lung Neoplasms
/
Antineoplastic Agents
Type of study:
Guideline
Limits:
Humans
Country/Region as subject:
Asia
Language:
Zh
Journal:
Chinese Journal of Lung Cancer
Year:
2022
Type:
Article