Explanation on the translation of American FDA orange peel book (drug approved by treatment equivalence evaluation)

Source: China Inspection Institute February 17, 2017 In order to help the industry select the reference preparation in the quality and efficacy consistency evaluation of generic drugs, with the approval of FDA office in China, the office of quality consistency evaluation of generic drugs organized the translation of the relevant contents of FDA orange peel book (drugs approved by the treatment equivalence evaluation), which is now published online for the industry's inquiry and reference If users need to quote, the original version shall prevail The purpose of this translation is to provide information reference and reference for consistency evaluation Users of translation shall not carry out commercial activities for the purpose of profit If you have any comments or suggestions on the translation content, you can contact the generic drug quality research center of the Chinese Academy of inspection in time Contact email: fzy@nifdc.org.cn 1, foreword of FDA Orange Book 2, how to use FDA Orange Book 3, list of prescription drugs in FDA Orange Book 4, list of over-the-counter drugs in FDA Orange Book 5, approved drugs supervised by biological evaluation and Research Center under the guidance of article 505 of the act List of banned drugs in FDA orange peel book Xlsx 7 Product name and approval list of American FDA orange peel Book orphan drug 8 Varieties of American FDA orange peel book that do not meet dissolution test and need bioequivalence test 9 Appendix of patent and exclusive right information of American FDA orange peel book (1) appendix of patent and exclusive right information of American FDA orange peel book (2) Appendix 2.xls (3) appendix 3.xlsx 2015 original English Pdf