The changes of manufacturing process and batch size of drug product as specified in the Appendix 12-1 should be applied to the central health competent authority for the applications of post-approval changes.The documents involving the above-mentioned changes shall be submitted as specified in Appendix 12-2.Appendix 12-1：Matters that Should be Applied for Changes of Manufacturing Process and Batch Size of Drug Product.pdfAppendix 12-2：Documents for the Application of Registration Changes of Manufacturing Process and Batch Size of Drug Product.pdf