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Commercialising therapeutic drugs in China: cross-border contract manufacture in doubt

China - August 3 2022 Since the introduction of a nationwide Marketing Authorization Holder (MAH) system in 2019, licenses have linked directly to therapeutic products…

Lingbi Li, Zhang Yunwei

Cross-Border CMO Structure Still in Doubt under China MAH Rules

China - June 23 2022 Since the introduction of a nationwide Marketing Authorization Holder (MAH) system in 2019, licenses have linked directly to therapeutic products…

Li Lingbi, Zhang Yunwei

药物警戒活动中个人信息处理的合法性基础

China - June 15 2022 《个人信息保护法》正式施行以来,各行各业都在探讨个人信息处理的合法合规性问题。医药企业在多个业务场景下都会处理个人信息,包括处理医疗健康信息在内的敏感个人信息。医药企业在每种业务场景下处理个人信息是否都有适当的合法性基础,以及应当依据何种合法性基础进行个人信息的处理,对于医药企业的合规经营殊为重要…

Jin Linyi

China relaxes rules on lab-developed tests - but uncertainties remain

China - May 19 2022 New regulations in China designed to encourage innovation in clinical trials have made it easier to test human samples in a lab setting. Lab tests on…

Zhang Yunwei

Developing Landscape of Chinese LDT Regulation

China - May 10 2022 Under the Chinese medical device regulatory regime, as filing/registration[1] is compulsory prior to marketization, the legality of use of…

Li Lingbi, Cui Yangyang, Zhang Yunwei