Regulations for Registration of Medicinal Products｜第 8 條｜Food and Drug Administration｜Regulation｜In Force
第 二 章/第 一 節｜衛生福利部｜v1.0
Effective Date: 2024-01-01｜Last Amended: 2023-04-27
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.