Regulations for Registration of Medicinal Products｜第 20 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
Drug labels, package inserts and packaging are subject to Article 75 of the Regulations, and can contain only the information approved by the central health competent authority. The statutory contents and presentation should comply with the following regulations and the print should be easy to read: 1.Package inserts should include information on drug category, packaging, storage and all compulsory matters required by other regulations; 2.The outer packaging of imported drugs should meet the following conditions: (1) The Product name, active ingredients and contents, and the name and address of the manufacturer or company should be printed by the original manufacturer. If the manufacturer’s name and address is not printed on the outer packaging, this information should be printed on a sticker adhering to the outer packaging; (2) The company name, address and license number of the drug company, drug category and Chinese product name can be provided on a sticker; (3) If the information of the manufacturer’s name and address is not printed on the outer packaging by the original manufacturer, it may be printed on a sticker with the information as stated above in the preceding item (2); and (4) For toll-manufactured products, with approval from the central health competent authority, the appointee’s name and address can be substituted by the country from where the appointee is located. 3.For generic drugs under pharmacovigilance, the package inserts should follow that of the first approved drug. For the registration or the changes in package inserts of generic drugs not under pharmacovigilance, the package inserts should follow the approved drug of the same active ingredient, same dosage form, same contents and same indication. The supplemented information on product characteristics and drug safety also can submit scientific evidence. It is not limited to those who have supplemented information on product characteristics and drug safety, and submitted scientific evidence for the contents of the supplement. The central health competent authority may ask for revising the package inserts if it is necessary. 4.The process of labelling is deemed a part of the manufacturing process and is subject to GMP Guidelines. For imported drugs, labelling should be done by the original manufacturer. Packaging and labelling can be commissioned to a GMP manufacturer or a GMP medical product distribution center in Taiwan, pursuant to the Guidelines on Drug Toll-Manufacturing and Contract Testing. Information about the GMP manufacturer or GMP medical product distribution center in Taiwan which packages and labels drugs in accordance with this paragraph may be exempted from the stickers. 5.Outer packaging and the immediate packaging have to be labelled in Chinese and English, pursuant to this article. If the immediate packaging does not have enough space to include information in both languages, at least product name and contents in Chinese should be provided. Labels listed below are deemed in compliance with this Paragraph. (1) Injections that are packed in one injection per box for single use with Chinese information printed on outer packaging; (2) Drugs that are sold or dispensed in original packaging with the outer boxes remaining intact, on which Chinese information is printed; or (3) Drugs that are classified by the central health competent authority to be used only by physicians with outer boxes printed with Chinese information. 6.For the following drug items, if Chinese information is provided on outer boxes, then only the Chinese or English product name and contents are required on the immediate packaging to meet the regulations in the preceding paragraph. (1) Drugs for rare diseases; (2) In situations where special storage conditions are required, i.e. drugs that need to be refrigerated or frozen; or (3) Special cases that the central health competent authority’s approval on drugs is required. 7.In principle, the information on package inserts should be within the pharmacological scope of its active ingredients and major efficacy. For compound preparations, the scope should be within the scope of the major pharmacological functions of mixed active ingredients. Exaggerated terms and wordings are not allowed. 8.Contraindications, warnings, side effects, and precautions stated on package inserts should be indicated in detail and printed in red, framed in red line, or in boldface to attract the special attention of users. 9.Chinese characters should not be smaller than font size seven. 10.Drugs sold on the market may only provide approved Chinese package inserts. However, if both Chinese and English package inserts are provided, the contents of the English version should be consistent with that of the Chinese one. Manufacturers may of their own accord modify the contents of the English version to fit the Chinese version. 11.Package inserts, labels and packaging materials should not include photos or wordings that are indecent, offensive or exaggerated. 12.If the distributor’s name is printed on the package inserts, labels or packing materials, the font size of the distributor’s name should not be bigger than that of the manufacturer (license holder). A photocopy of the distributor’s business license should be submitted for reference. 13.The font size of the Chinese product name should not be smaller than that in foreign language. The printing should be clear. As a standard for comparison, the height of the printing of product name in Chinese should not be lower than that in foreign language. 14.For OTC (Over-the-counter) drugs, the labels and packaging should include significant prints of the product category, i.e. OTC drugs or Class B OTC drugs. In principle, printing should be in regular fonts. 15.Whereas the active ingredients, dosage form, dose and administration route of a licensed drug remain unchanged, the appearances or shapes of its aromatics, coloring agents or corrective agents without any pharmacological effects are altered but do not affect drug quality or medication safety, then it can be justified by applying for post-approval changes for excipients as the addition of new contents. Appropriate descriptions should be given on labels, package inserts and outer packaging for clear differentiation. Graphic designs and colors may be changed to suit the new descriptions. 16.For drugs packed in aluminum blister foils, each sheet of foil should be printed with the drug name using Chinese as the main language. Manufacturer’s name and license number can be provided. The following conditions are deemed to meet the criteria of this Paragraph: (1) The product name in Chinese has been printed on (or adhered to) the immediate packaging of each aluminum blister foil sheet; (2) Drugs are dispensed or sold in original packaging with the outer boxes remaining intact, on which information in Chinese is printed. 17.Drug labels and packaging should contain information of batch number, manufacturing date, effective period and expiry date in any of the following format: (1) batch number, manufacturing date and effective period; (2) batch number and expiry date; or (3) batch number, manufacturing date and expiry date. 18.The manufacturing date and expiry date as mentioned in the preceding paragraph should be written with Arabic numbers using four-digit format for year. When only month and year are shown for the expiry date, either year-month or month-year format is accepted. For manufacturing date and expiry date containing all three components (year, month, day), the date should be written in the year-month-day format (from left to right). If other date notations are used due to unavoidable circumstance, the format used (e.g., dd/mm/yyyy, day/month/year, etc.) should be clearly expressed on the outer box. But, for products whose validity period is over 2 years, the manufacturing date and expiry date can include year and month only and set at the last day of that labelled month as the expiry date. 19.Information of the materials that have direct contact with pharmaceutical products should be labelled on plastic containers of L.V.P. (large volume package) for infusion. 20.The active ingredient(s) and excipients should be labelled respectively in the package inserts. The excipients may be written in chemical name or trade name, and the excipients not existing in the final product may not be listed. 21. For new drug registration or change in package inserts of prescription drugs, the drafts of package inserts should follow the format (prescription drug’s package insert format in Appendix 1-1). Concerning locally manufactured drugs for exportation, shall not be subject to the limitations set forth in the preceding paragraph Subparagraph 1-3,5-10,12-14 and 16-21. Statutory package inserts, labels, outer boxes, aluminum blister foils and other materials or graphic for labelling purpose should comply with the additional items required to be printed as announced by the central health competent authority, as well as the drug re-evaluation results, Guidelines on the Review of OTC Drugs, drug re-categorization and regulations of standardized package inserts. In addition to the regulations set out in previous three paragraphs, the additional printings on labels and packaging of controlled drugs should also comply with the Regulations Governing Controlled Drugs as well as other related regulations. Color drafts of outer boxes, package inserts, labels, aluminum blister foils and other labelling materials should be adhere to the form for sticking label and package insert. The affixing form can be exempted, if the documents said in the preceding paragraph are submitted via the electronic submission platform. When collecting license, applicant should submit the electronic files of the image of drug appearance, labels, package insert and packaging as approved by the central health competent authority. For applications of post-approval changes in drug appearance, labelling, package insert or packaging, electronic files of the new contents approved by the central health competent authority should be submitted.