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

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Chapter

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 1 General Principles § 1

Chapter 2 Western Medicine § 4

Section 1 General Provisions § 4

Section 2 Drug Review and Registration § 32

Section 3 Post-Approval Changes § 45

Section 4 License Transfer, Renewal and Reissuance § 70

Section 5 License Extension § 72

Chapter 3 Chinese Medicine § 74

Section 1 General Provisions § 74

Section 2 Chinese Medicine Review and Registration § 91

Section 3 Post-Approval Changes of Chinese Medicine § 97

Section 4 Chinese Medicine License Transfer, Replacement, and Reissuance § 108

Section 5 Chinese Medicine License Extension Registration § 109

Chapter 4 Supplementary Provisions § 110