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JIN Yu, YAO Dongning, SHAO Rong. Development and regulation of biological products in China[J]. Journal of China Pharmaceutical University, 2014, 45(3): 378-382. DOI: 10.11665/j.issn.1000-5048.20140323
Citation: JIN Yu, YAO Dongning, SHAO Rong. Development and regulation of biological products in China[J]. Journal of China Pharmaceutical University, 2014, 45(3): 378-382. DOI: 10.11665/j.issn.1000-5048.20140323

Development and regulation of biological products in China

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  • The development and the status quo of domestic and foreign biopharmaceutical industries are introduced, and the supervision system of biological medicine in China is elaborated. The approval of biologics, the pre-marketing batch-release system for biological products, quality control standards, as well as the post-marketing adverse reaction monitoring system are reviewed, aiming to provide some references for the development and regulation of Chinese biopharmaceutical products.
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