Information that should be submitted for the application for drug registration of new drugs, new dosage forms, new administration doses or new unit strength are as specified in Appendices 2 and 3.Regulations for new drugs stipulated in this Chapter are also applicable to pharmaceutical preparations with new dosage forms, new administration doses and new unit strengths.Appendix 2：Documents for the Application forDrug Review and Registration of New Drugs, New Dosage Forms, New Administration Doses and New Unit Strengths.pdfAppendix 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