Regulations for Registration of Medicinal Products Article 25
In any of the following situations, applications will be rejected:1.Applicants don’t have the qualifications required, or manufacturing equipment does not meet the standard, e.g. hardware, software or dosage form equipment does not comply with GMP Guidelines; or there has been no submission of evidence to support compliance with related regulations;2.No application fees have been paid, or the submitted data is insufficient or does not fit with the contents of the application;3.The major efficacy of the applied drug is unclear or insignificant; or the drug fails the drug re-evaluation;4.The applied drug has severe side effects or safety concerns;5.The contents of toxins or controlled substances contained in the applied drug do not conform to regulated doses;6.The applied drug contains unapproved coloring agents, preservatives or anti-oxidants;7.The applied drug contains forbidden ingredients;8.The applied drug has inappropriate formula, manufacturing method or dosage form;9.The ingredients of an oral liquid product are not nutrients, or contain Caffeine-like substance;10.Hormone (including anabolic hormones, steroid), stomachics, pesticides, sickness drugs or pharmaceutical preparations with effects of anti-sleep, antipyretic, antitussive, expectorants or other medical efficacy, that are registered in the dosage form of oral liquid;11.Amino acid and multi-vitamin nutrition that in total contain over 8% w/v of alcohol;12.Syrup containing codeine (phosphate) with the content of sucrose less than 55 w/v; or syrup categorized as Over-the-counter (OTC) drugs with the content of codeine less that 1g per 100ml and in compliance with the following rules about the content of codeine:(1)The maximum daily dose is 9 mg for syrup for the cold and 18mg for syrup for antitussive or expectorants;(2)For concomitant use with Ephedrine Hydrochloride, dl-Methylephedrine Hydrochloride, the dose should be reduced by 20%;(3)The single dose for an adult should be at least 5ml; and the formula’s unit strength should be adjusted accordingly.13.Pharmaceutical preparations combined with Chinese traditional medicine and western pharmaceutical medicines that contain substances affecting the central nerve system, poisons or powerful drugs;14.Inappropriate testing specifications or data references;15.Failing to collect licenses or proceed with drug testing within the specified deadline; or the drug testing results fail the assessment due to discrepancy between the results and the data submitted for the application or due to other reasons;16.Failing to produce, change or modify the product packaging, labels or package inserts in accordance with the approved items; and17.Any other situations not in compliance with the Regulations, related regulations, or announcements made by the central health competent authority.
中文原文 藥品查驗登記審查準則第25條
申請案件有下列情形之一者，不予核准：
一、申請人資格不合或製造設備不符，包括其軟硬體設備及相關劑型設備不符合藥品優良製造規範或未依規定提出符合該規範之證明文件影本。
二、未依規定繳納費用或檢附之資料不充足或與申請案件內容不符。
三、申請之藥品，主治效能不明確或無顯著療效、或未通過藥品再評估。
四、申請之藥品有嚴重副作用或具安全疑慮。
五、申請之製劑所含毒劇或管制藥品不符規定之劑量。
六、申請之藥品含有未經核准使用之著色劑、防腐劑、抗氧化劑。
七、申請含有禁止使用之成分。
八、申請之藥品，處方、製法或劑型不適當。
九、口服液製劑成分非營養保健，或含有Caffeine類之成分。
十、激素（包括蛋白同化荷爾蒙、類固醇類）、胃腸藥、驅蟲劑、鎮暈劑及具抗睡眠、解熱、鎮痛、鎮咳、袪痰或其他具醫療效能之製劑，以口服液登記。
十一、胺基酸類及多種維生素類營養劑之含醇總量超過8%W/V。
十二、含可待因（磷酸鹽）之糖漿劑，含蔗糖量未滿百分五十五W/V者；或可待因糖漿製劑含量每一百毫升未滿一公克而列屬於指示用藥，其可待因含量不符下列規定：
（一）一日最大配合量，感冒糖漿劑九毫克，鎮咳、袪痰糖漿劑十八毫克。
（二）如與EphedrineHydrochloride、dl-MethylephedrineHydroc-hloride配合時，應減量百分之二十。
（三）成人每次服用量應為五毫升以上，處方單位含量應配合調整。
十三、含有影響中樞神經及毒藥、劇藥之中西藥混合製劑。
十四、檢送之檢驗規格或資料文獻不適當。
十五、未於規定期限內辦理領證或送驗手續，或送驗之藥品經檢驗與申請資料不符或其他原因不合格者。
十六、未依核定事項刊載、修正或變更藥品之包裝、標籤或仿單。
十七、其他不符本準則或有關法令規定，或不符中央衛生主管機關公告事項之情形。
一、申請人資格不合或製造設備不符，包括其軟硬體設備及相關劑型設備不符合藥品優良製造規範或未依規定提出符合該規範之證明文件影本。
二、未依規定繳納費用或檢附之資料不充足或與申請案件內容不符。
三、申請之藥品，主治效能不明確或無顯著療效、或未通過藥品再評估。
四、申請之藥品有嚴重副作用或具安全疑慮。
五、申請之製劑所含毒劇或管制藥品不符規定之劑量。
六、申請之藥品含有未經核准使用之著色劑、防腐劑、抗氧化劑。
七、申請含有禁止使用之成分。
八、申請之藥品，處方、製法或劑型不適當。
九、口服液製劑成分非營養保健，或含有Caffeine類之成分。
十、激素（包括蛋白同化荷爾蒙、類固醇類）、胃腸藥、驅蟲劑、鎮暈劑及具抗睡眠、解熱、鎮痛、鎮咳、袪痰或其他具醫療效能之製劑，以口服液登記。
十一、胺基酸類及多種維生素類營養劑之含醇總量超過8%W/V。
十二、含可待因（磷酸鹽）之糖漿劑，含蔗糖量未滿百分五十五W/V者；或可待因糖漿製劑含量每一百毫升未滿一公克而列屬於指示用藥，其可待因含量不符下列規定：
（一）一日最大配合量，感冒糖漿劑九毫克，鎮咳、袪痰糖漿劑十八毫克。
（二）如與EphedrineHydrochloride、dl-MethylephedrineHydroc-hloride配合時，應減量百分之二十。
（三）成人每次服用量應為五毫升以上，處方單位含量應配合調整。
十三、含有影響中樞神經及毒藥、劇藥之中西藥混合製劑。
十四、檢送之檢驗規格或資料文獻不適當。
十五、未於規定期限內辦理領證或送驗手續，或送驗之藥品經檢驗與申請資料不符或其他原因不合格者。
十六、未依核定事項刊載、修正或變更藥品之包裝、標籤或仿單。
十七、其他不符本準則或有關法令規定，或不符中央衛生主管機關公告事項之情形。