This guideline is applicable to the manufacture of the finished dosage form of chemical
and herbal medicinal products for human use intended for marketing authorisation. It
also applies to variations for authorised products in cases where changes to the
manufacturing process affecting the MA are proposed.
这份指南适用于为取得上市许可证的人用化学药品和植物药品制剂成品生产。同时，它也适用于已
经批准的产品在计划实施变更生产工艺影响MA的变更情况。
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发表于 2018-1-12 10:02:31
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