An applicant of registration of changes in excipients of Chinese medicine products shall have samples tested and the following documents and data submitted:1. Application form for post-approval changes;2. Original copy of the drug license;3. Two copies each of the originally approved outer boxes, package inserts, and labels and the forms for sticking the outer boxes, package inserts, and labels to be used instead;4. Photocopy of batch records;5. Two copies each of the following documents: testing specifications for finished products, testing methods for finished products, records of general inspection for finished products, testing report on finished products, and the identification test results (including chromatographic maps or other documents sufficient for confirmations); the testing items and specifications shall comply with Appendix 13 and the announcements made by the central health competent authority;6. Documentation procedures and reports of stability tests;7. Testing specifications, methods, and reports of new excipients.In the event that the application set forth above only involves coloring agents or capsule shell changes, without any impact on the characteristics, pharmacological effects, quality and safety of the original medicine, the following documents and data shall be submitted, and drug testing can be exempt:1. Documents and data set forth in Subparagraphs 1 to 3 of the preceding paragraph.2. Manufacturing and Control Standard.3. Testing specifications and methods for finished products.For an imported Chinese medicine under the change registration application in the preceding two paragraphs, a letter of notification of post-approval changes issued by the original manufacturer and the original FSC from the country of origin are also required.