对我国附条件批准上市化药药学技术要求的思考
Considerations on the chemistry, manufacture and control requirements for conditional marketing authorization drugs in China
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摘要: 我国2019年修订的《药品管理法》首次在法律层面提出附条件批准上市，标志着我国正式实施附条件批准上市制度。本文通过比较我国与欧美地区附条件批准上市药品的法规与技术要求，借鉴欧美地区对附条件批准化学药品的药学审评经验，探讨我国附条件批准上市化学药品的药学审评技术要求。Abstract: Drug Administration Law revised in 2019 proposed for the first time conditional marketing authorization at the legal level, marking the formal implementation of the conditional marketing authorization in China. This paper compares the regulations and technical requirements of conditional marketing authorization drugs in China with those in Europe and the United States, in an attempt to learn from the experience of chemistry, manufacture and control review of these drugs in Europe and the United States, and to discuss the pharmaceutical technical requirements of conditional marketing authorization drugs in China.
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