The changes in dosage forms of Chinese medicine products are limited to the changes from concentrated powders to concentrated granules, or vice versa, of standard formulas announced by the central health competent authority. Other changes in dosage forms shall be processed by filing a new application.An applicant of registration of changes in dosage forms 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. Application form for drug review and registration;4. Assurance Statement (A);5. 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;6. Form for sticking licenses and certificates;7. Photocopy of batch records;8. 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;9. Documentation procedures and reports of stability tests;10. In the case of imported Chinese medicine, 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.