Regulations for Registration of Medicinal Products Article 8
Except as otherwise regulated, the formulation basis mentioned in this Chapter refers to the pharmacopoeia or official reference books published in the A10 countries of editions published within 5 years from the date of application.Formulation basis should meet the following criteria; its title, edition, year of publication and page numbers should all be indicated. A photocopy of complete reference pages should be provided. If the reference is in neither Chinese nor English, a word for word Chinese translation should be provided; but proper names or technical terms can be listed in English.1.If USP is submitted, then the USPDI shall also be provided for assessment. Extra pharmacopoeia, which is not an official reference book, is for reference only.2.If the applied formula is not completely consistent with the submitted reference and some alternations have been made, a statement explaining the alternation should be provided. Information in relation to the actual changes should be submitted as appropriate.3.Tablets, film-coated tablets and sugar-coated tablets can use the same formulation basis, but not for enteric-coated tablets.4.The formulation basis of ointment and cream can be used interchangeably, provided that the products are not under pharmacovigilance.5.If the formulation basis or the CPP is of tablets, the reasons for the application of double-layered tablets should be given. Moreover, the package inserts and labels shall not include exaggerated therapeutic effects associated with the dosage form. Any boost of effects due to dosage forms should be approved and justified by clinical data before they can be indicated in package inserts or labels.6.If the formulation basis submitted by local manufacturers for drug registration is not pharmacopoeia or reference books published by the A10 countries, the Orange Book or USPDI published by the US FDA can be used instead.New drugs, new dosage forms, new administration doses or new unit strength developed in Taiwan do not need to submit formulation basis. However, the researches of formulation design and technical data in relation to this drug should be submitted.
中文原文 藥品查驗登記審查準則第8條
本章所稱處方依據，除別有規定外，以十大醫藥先進國家出版之藥典或公定書為準，並以出版日起五年內之版本為限。
檢附處方依據，應符合下列規定，並記載所據書名、版次、年次及頁數，檢附完整依據之影本；如所附依據非中文或英文者，除專有名詞得以英文列出外，應逐字翻譯成中文。
一、如檢附USP者，應同時附USPDI供審核。
非屬公定書之ExtraPharmacopoeia，僅供參考。
二、處方與所附依據未盡相符而有變更時，應附具理由書，並視實際變更情形檢附有關必要資料。
三、錠劑、膜衣錠、糖衣錠，得使用相同處方依據。
但腸溶錠不得以錠劑、膜衣錠、糖衣錠為處方依據。
四、軟膏與乳膏之處方依據或採用證明，如非列入監視藥品者，得互用之。
五、如以錠劑為處方依據或採用證明者，申請雙層錠或子母錠時，應說明製成雙層錠或子母錠之理由，且不得藉劑型於仿單、標籤中誇大療效。
如藉由劑型以達相乘或加大效果者，廠商於檢附臨床資料並經審查核准後，得於仿單、標籤上增列之。
六、國內廠商申請查驗登記所檢附之處方依據，如非屬十大醫藥先進國家出版之藥典或公定書者，得以美國FDA之Orangebook或USPDI替代之。
由國內自行研發之新藥、新劑型、新使用劑量、新單位含量製劑，免附處方依據。
但應另附處方設計研究及該藥品之技術性資料。
檢附處方依據，應符合下列規定，並記載所據書名、版次、年次及頁數，檢附完整依據之影本；如所附依據非中文或英文者，除專有名詞得以英文列出外，應逐字翻譯成中文。
一、如檢附USP者，應同時附USPDI供審核。
非屬公定書之ExtraPharmacopoeia，僅供參考。
二、處方與所附依據未盡相符而有變更時，應附具理由書，並視實際變更情形檢附有關必要資料。
三、錠劑、膜衣錠、糖衣錠，得使用相同處方依據。
但腸溶錠不得以錠劑、膜衣錠、糖衣錠為處方依據。
四、軟膏與乳膏之處方依據或採用證明，如非列入監視藥品者，得互用之。
五、如以錠劑為處方依據或採用證明者，申請雙層錠或子母錠時，應說明製成雙層錠或子母錠之理由，且不得藉劑型於仿單、標籤中誇大療效。
如藉由劑型以達相乘或加大效果者，廠商於檢附臨床資料並經審查核准後，得於仿單、標籤上增列之。
六、國內廠商申請查驗登記所檢附之處方依據，如非屬十大醫藥先進國家出版之藥典或公定書者，得以美國FDA之Orangebook或USPDI替代之。
由國內自行研發之新藥、新劑型、新使用劑量、新單位含量製劑，免附處方依據。
但應另附處方設計研究及該藥品之技術性資料。