When applying for Chinese medicine registration, the applicant shall provide photocopies of documents to justify that the hardware, software, and relevant dosage form equipment of the manufacturers have complied with the Good Manufacturing Practice for Medicinal Products. For toll-manufactured products, the manufacturers shall include those commissioned to engage in any and all of the manufacturing processes outsourced in different stages.

The application form and following documents and data are required for applications for the registration of domestically manufactured Chinese medicine:
1. Assurance Statements (A) and (B); Assurance Statement for Export Only (C) is also required if an application is simultaneously submitted for the name used for export only;
2. Two copies each of the forms for sticking outer boxes, package inserts, and labels;
3. Form for sticking licenses and certificates;
4. Photocopy of the formulation basis;
5. Photocopy of batch records;
6. Two copies each of the forms for testing specifications for finished products, testing methods for finished products, records of general inspection for finished products, testing report for finished products, and 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;
7. The standard operating procedures for stability testing, and reports of stability tests, furthermore, of all the stability tests should comply with The standards for stability tests of Chinese medicine products announced by the central health competent authority;
8. For formulas not approved by the central health competent authority to be included in the well-established publications, testing methods, specifications, and 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;
9. 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.
The application form and following documents and data are required for applications for the registration of Chinese medicine for export only:
1.The documents and data required in Subparagraphs 1 to 5 of the preceding paragraph and the standard operating procedures for stability testing as set forth in subparagraph 7.
2.Testing specifications for finished products, testing methods for finished products, records of general inspection for finished products, and testing report for finished products. Except for the identification test, the testing items and specifications shall comply with Appendix 13 and the announcements made by the central health competent authority, otherwise in accordance with the regulation of the country of destination.
The Chinese medicine for export only stated in the preceding paragraph should conduct the stability testing and have a written report which is retained in the pharmaceutical factory for future inspection. The stability test should comply with The standards for stability tests of Chinese medicine products announced by the central health competent authority.

• Appendix 13.pdf

Any person submitting the application specified in Paragraph 1 of the preceding article may remove any Chinese medicine materials or ingredients banned by the importing country from the formula listed in the license held for a domestically manufactured Chinese medicine and may use the revised formula as the formulation basis set forth in Subparagraph 4 of Paragraph 1 of the preceding article when applying for registration of the Chinese medicine, without being subject to the restrictions set forth in Paragraphs 1 and 2 of Article 75.
The manufacturer listed in the drug license issued upon the registration specified in the preceding paragraph is limited to the one listed in the license for the domestically manufactured Chinese medicine specified in the preceding paragraph. However, this does not apply in the event of a change of the manufacturer in accordance with Paragraph 1 of Article 106 or Article 107.
For applications for registration in accordance with Paragraph 1, the batch records required in Subparagraph 5 of Paragraph 1 of the preceding article may be replaced by the Manufacturing and Control Standard. Moreover, submission of the records of general inspection for finished products, testing report for finished products, and the identification test results (including chromatographic maps or other documents sufficient for confirmations), as set forth in Subparagraph 6 of Paragraph 1 of the preceding article, as well as the reports of stability tests, as set forth in Subparagraph 7, is not required.

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.

The following documents and data are required for applications for the registration of new Chinese medicine:
1. The registration application form and other documents;
2. Domestic clinical trial reports;
3. Technical data required by the central health competent authority as listed in official announcements.
In the event that the clinical trial report is difficult to conduct by local clinical trials, supporting data applicable to the Taiwanese people may be otherwise submitted for the application of adoption of foreign clinical trial data, which may be recognized only upon the approval by the competent central health competent authority.

Licenses for drugs in the same dosage form but of different doses shall be applied for separately.

A manufacturer may, in one month, submit two applications for the registration of compound preparations, or six applications for single ingredient preparations, or one application for compound preparations plus three applications for single ingredient preparations, unless the manufacturer has applied to the central health competent authority for special approval by giving reasons and providing relevant data.
The relevant data set forth in the preceding paragraph shall include information on the equipment and technical professionals of the drug manufacturing and quality control departments and other relevant information. When necessary, the central health competent authority may assign personnel to conduct on-site inspections of the quality control, production records, sample manufacturing processes and on-site supervision.
Each application for special approval, as set forth in Paragraph 1, shall involve up to 24 cases.