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Regulations for Registration and Permission of Regenerative Medicinal Products
1.中華民國一百十四年十二月四日衛生福利部衛授食字第 1141402018 號 令訂定發布全文 13 條；依第 13 條規定：自再生醫療製劑條例施行之 日施行 中華民國一百十四年十二月三十日行政院院臺衛字第 1141035478 號令 發布「再生醫療製劑條例」定自一百十五年一月一日施行
資料來源：全國法規資料庫（ChOrder.json，版本 2026/7/24 上午 12:00:00）・政府資料開放授權
The Regulations are prescribed in accordance with Paragraph 3 of Article 8 of the Regenerative Medicinal Products Act (hereinafter referred to as “the Act”).
The product name of regenerative medicinal products shall comply with the provisions of Article 14 of the Regulations for Registration of Medicinal Products. For regenerative medicinal products with conditional approval, the provisions of Subparagraph 6 of Paragraph 1 and Paragraph 3 of that article shall apply mutatis mutandis.
For regenerative medicinal products with conditional approval, the content, format, font, and other documents and materials to be submitted at the time of application for labels, package inserts, and packaging shall comply with the provisions of Paragraphs 1 through 5 of Article 20 of the Regulations for Registration of Medicinal Products. Upon receipt of the conditional approval letter, the provisions of Paragraph 6 of that article shall apply mutatis mutandis.
Applications for registration and market approval of regenerative medicinal products and for the issuance of drug licenses or conditional approval shall be accompanied by documents and materials in accordance with the provisions of Appendices 1 and 2.
Applicants for conditional approval shall submit a written explanation of the matters listed in each subparagraph of Paragraph 1, Article 10 of the Act at the time of application.
1Applicants for registration and issuance of conditional approval, upon receiving notification to collect the conditional approval letter, shall collect it within three months and complete the following procedures. Failure to collect within the prescribed time limit shall result in rejection:
21. Submit two copies each of labels, package inserts, and packaging that have been printed according to the approved draft, or two copies each of color drafts. For submissions via the electronic submission platform, only one copy of each item or color draft is required.
32. Complete the following filing operations on the drug package insert inquiry platform:
4(1) Drug appearance.
5(2) Labels, package inserts, and packaging approved by the central competent authority.
63. Submit the original notification letter for collection bearing the stamps of the applicant and the person in charge of the institution.
74. Submit the following documents and materials originally attached to the notification letter for collection:
8(1) Approved drafts of labels, package inserts, and outer packaging.
1When pharmaceutical firms apply for registration and market approval of regenerative medicinal products, in addition to clinical trial reports, they may provide Real-World Evidence (RWE) as supplementary evidence for the review of drug efficacy and safety.
2For the clinical trial reports and Real-World Evidence specified in the preceding paragraph, the selection of trial design or analytical methods may incorporate Patient-Focused Drug Development (PFDD) as one part of the drug risk-benefit evaluation and assessment.
1The Real-World Evidence referred to in the preceding article means evidence obtained through appropriate analytical methods using data obtained in real-world settings from the following sources:
21. Medical records or other health records.
32. Health insurance databases.
43. Research data from before and after drug marketing.
54. Patient or disease registry databases.
65. Other data sources that contribute to generating Real-World Evidence.
When applying for registration and market approval of regenerative medicinal products, if the central competent authority deems laboratory testing necessary, it may require pharmaceutical firms to submit samples for inspection.
For applications for change registration of conditional approval, the provisions regarding change registration of drug licenses in the Regulations for Registration of Medicinal Products shall Apply Mutatis Mutandis.
For applications for transfer registration of conditional approval, the provisions regarding transfer registration of drug licenses in the Regulations for Registration of Medicinal Products shall Apply Mutatis Mutandis.
For applications for registration and market approval of regenerative medicinal products, change registration and transfer registration of drug licenses and conditional approval, as well as extension, reissuance, and replacement of drug licenses, matters not provided for in these Regulations shall be governed by the Regulations for Registration of Medicinal Products, other relevant laws and regulations, and matters in official notices of the central competent authority.
The Regulations shall come into effect on the day when the Act becomes effective.
10(3) Photocopy of the conditional approval letter.
11Where the applicant completes the operations specified in the preceding paragraph within the prescribed time limit, but the submitted labels, package inserts, packaging, or other related items, documents, or materials contain errors requiring correction and reprinting, corrections shall be made within the time limit notified by the central competent authority. The conditional approval letter may only be collected after corrections have been made.
12For registration and market approval, if the Pharmaceutical Good Manufacturing Practice compliance certificate, Western Pharmaceuticals Good Distribution Practice compliance certificate, and Certificate of Pharmaceutical Product from the country of origin cannot be submitted at the time of application, they shall be supplemented and completed before collecting the conditional approval letter.