Title： Regulations for Registration of Medicinal Products
Amended Date： 2020-06-12
Category： Ministry of Health and Welfare

Attachment：
Appendix 1:
Maximum Drug Package Size

Appendix 2:
Documents for the Application for Drug Review and Registration of New Drugs, New Dosage Forms, New Administration Doses and New Unit Strengths

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

Appendix 4:
Documents for the Application for Drug Review and Registration of Generics

Appendix 5:
Technical Documents for the Application for Drug Review and Registration of Generics in the Dosage Forms of Liposome or Transdermal Absorption

Appendix 6:
Documents for the Application for Drug Review and Registration of Bio-Pharmaceutical Products

Appendix 7:
Technical Documents for the Application of Drug Review and Registration of Bio-Pharmaceutical Products

Appendix 8:
Documents for the Application of Drug Review and Registration of API

Appendix 9:
Technical Documents for the Application of Drug Review and Registration of API

Appendix 10:
Documents Required for the Application for Drug Review and Registration of Radiopharmaceutical Drugs

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

Appendix 12:
Documents for the Application of Registration Change of API Technical Document

Appendix 13:
Table for Mandatory Items and Contents of Chinese Medicine Specifications and Testing Methods