Regulations & Policies
[Taiwan] Regulations for Registration of Medicinal Products
2020-06-12

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

Information appearing on this website (images and texts, unless otherwise indicated) is the property of IBMI. To use or share, please indicate the source.
©Institute for Biotechnology and Medicine Industry (IBMI) All rights reserved.
Address:16F.-1, No.3, Park St., Nangang Dist., Taipei City 115, Taiwan (R.O.C.) Contact Number:(02)2655-8168 Fax:(02)2655-7978