Regulations for Registration of Medicinal Products Article 32
When applying for drug registration, the applicant should provide photocopies of documents to justify that the hardware, software and dosage form equipment of the manufacturers comply with the GMP Guidelines. For toll-manufactured products, the paperwork should include all manufacturers involved in every step of the manufacturing process.Active ingredients of drug products shall comply with GMP Guidelines.
中文原文 藥品查驗登記審查準則第32條
申請藥品查驗登記，其製造廠之軟硬體設備及相關劑型設備，應符合藥品優良製造規範，並提出符合該規範之證明文件影本。
如係分段委託製造者，其製造廠應包括分段委託製造中所有製程涉及之受託製造廠。
製劑使用之原料藥應符合藥品優良製造規範。
如係分段委託製造者，其製造廠應包括分段委託製造中所有製程涉及之受託製造廠。
製劑使用之原料藥應符合藥品優良製造規範。