Regulations for Registration of Medicinal Products Article 91
When applying for Chinese medicine registration, the applicant shall provide photocopies of documents to justify that the hardware, software, and relevant dosage form equipment of the manufacturers have complied with the Good Manufacturing Practice for Medicinal Products. For toll-manufactured products, the manufacturers shall include those commissioned to engage in any and all of the manufacturing processes outsourced in different stages.
中文原文 藥品查驗登記審查準則第91條
申請中藥查驗登記，其製造廠之軟硬體及相關劑型設備，應符合藥品優良製造規範，並提出證明文件影本；屬分段委託製造者，其製造廠應包括分段委託製造中所有製程之受託製造廠。