Regulations for Registration of Medicinal Products - Chapter - Laws & Regulations Database of The Republic of China (Taiwan)

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Chapter Law Content

Title：	Regulations for Registration of Medicinal Products CH
Category：	Ministry of Health and Welfare（衛生福利部）
Attachment：	Appendix1：Maximum Drug Package Size Dosage.pdf Appendix 1-1：Prescription Drug’s Package Insert Format.pdf Appendix 2：Documents for the Application forDrug Review and Registration of New Drugs, New Dosage Forms, New Administration Doses and New Unit Strengths.pdf Appendix 3：Technical Documents for the Application for Drug Review and Registration of New Drugs, New Dosage Forms, New Administration Doses and New Unit Strengths.pdf Appendix 4：Documents for the Application for Drug Review and Registration of Generics.pdf Appendix 5：Technical Documents for the Application for Drug Review and Registration of Generics in the Dosage Forms of Liposome or Transdermal Absorption.pdf Appendix 6：Documents for the Application for Drug Review and Registration of Bio-Pharmaceutical Products.pdf Appendix 7：Technical Documents for the Application of Drug Review and Registration of Bio-Pharmaceutical Products.pdf Appendix 8：Documents for the Application of Drug Review and Registration of API.pdf Appendix 9：Technical Documents for the Application of Drug Review and Registration of API.pdf Appendix 10：Documents Required for the Application for Drug Review and Registration of Radiopharmaceutical Drugs.pdf Appendix 11：Technical Documents Required for the Application for Drug Review and Registration of New Drugs, New Dosage Forms and New Dose of Radiopharmaceutical Drugs.pdf Appendix 12.PDF Appendix 12.doc Appendix 12-1：Matters that Should be Applied for Changes of Manufacturing Process and Batch Size of Drug Product.pdf Appendix 12-2：Documents for the Application of Registration Changes of Manufacturing Process and Batch Size of Drug Product.pdf Appendix 13.pdf

Chapter 4 Supplementary Provisions

Article 110

The Regulations take effect on the date of promulgation.
The provisions of Article 53, Article 39 related Appendix 2, and Article 40 related Appendix 4 amended on April 6th, 2016 in this Regulation shall come into force as of July 1st, 2017; The provision of Article 92 Paragraph 3 amended on July 31th, 2017 in this Regulation shall come into force as of January 1st, 2019; The provisions of article 42 related Appendix 8, the photocopy of the API for Exportation GMP compliance certificate dated within the past 2 years, amended on September 14th , 2021 in this Regulation shall come into force as of January 1st, 2022; The provisions of Article 46, 56, 62, 64 and 70 amended on April 27th, 2023 in this Regulation shall come into force as of January 1st, 2024.