Regulations for Registration of Medicinal Products｜第 93 條｜Food and Drug Administration｜Regulation｜In Force
第 三 章/第 二 節｜衛生福利部｜v1.0
Effective Date: 2024-01-01｜Last Amended: 2023-04-27
The following documents and data are required for applications for the registration of imported Chinese medicines: 1. Original copy of the authorization letter; 2. Original copy of the FSC from the country of origin and a copy of the Chinese translation; 3. Application form for drug review and registration; 4. Assurance Statements (A) and (B); 5. Two copies each of the forms for sticking outer boxes, package inserts, and labels; 6. Form for sticking licenses and certificates; 7. Photocopy of the formulation basis; 8. Photocopies of batch records for the same lot as the testing samples; 9. Two copies of documents specifying the testing specifications and methods for raw materials and finished products in Chinese or in English; the following regulations shall also be observed: (1) Each ingredient (including main ingredients and excipients) of the formula shall be indicated; if the ingredients used are based on a pharmacopoeia, a photocopy of the description of such ingredients in the pharmacopoeia shall also be provided; (2) The testing items and specifications for finished products shall comply with Appendix 13 and the announcements made by the central health competent authority 10. Two copies of the testing reports on raw materials and finished products; the following regulations shall also be observed: (1) The batch number, testing date, product names, and signatures of the persons in charge of testing and supervision shall be provided; (2) The batch number indicated on the testing report on each ingredient (including main ingredients and excipients) of the formula shall be the same as that of the raw materials used for the finished products. The raw materials and finished products shall be tested for each specification criterion. 11. Documentation procedures and reports of stability tests; 12. For formulas not approved by the central health competent authority to be included in the well-established publications, testing methods, specifications, and a graph spectra of the content of one marker ingredient are required in the case of single ingredient preparations; those of two or more marker ingredients are required in the case of compound preparations. However, those deemed by the central health competent authority as having difficulties in satisfying such requirements may be exempted; 13. For applications for any formula listed in the drug license of another drug company as the formulation basis, testing or inspection data identical to those submitted when the drug concerned is approved shall also be provided.