For active pharmaceutical ingredients or active pharmaceutical ingredients of drug products with licenses, the data involving the changes of technical documents shall be submitted in accordance with Appendix 12.When applying for addition or change of the source of active pharmaceutical ingredients of the drug products, the following documents shall be submitted:1. Application form for post-approval changes;2. Original drug license;3. A GMP compliance certificate for the active pharmaceutical ingredients newly added or changed;4. The approvals of the technical documents of the active pharmaceutical ingredients issued by the central competent health authority. However, the technical documents of active pharmaceutical ingredients can be substituted by other dossiers as promulgated by the central competent health authority.5. Description of the differences in specification between the new and old source of active pharmaceutical ingredient and the evidence;6. Comparison and evaluation data of the finished preparations according to the characteristics of the dosage forms;7. If the results compared according to the preceding paragraph are inconsistent, a dissolution test shall be conducted. If the comparison results of dissolution curves are dissimilar (f2<50), a drug BE test report shall be submitted.Appendix 12.PDFAppendix 12.doc