Regulations for Registration of Medicinal Products Article 40

Information that should be submitted with the application for drug registration of generic drugs are as specified in Appendices 4 and 5.Appendix 4：Documents for the Application for Drug Review and Registration of Generics.pdfAppendix 5：Technical Documents for the Application for Drug Review and Registration of Generics in the Dosage Forms of Liposome or Transdermal Absorption.pdf