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