The testing specifications for Chinese medicine, as provided in this Chapter, are based on the Taiwan Herbal Pharmacopeia, Chinese Pharmacopoeia, or other foreign pharmacopoeias or announcements acknowledged by the central health authority. References can only be taken from the last two editions; nevertheless, the testing specifications for Chinese medicine preparation shall be based on the latest edition of the Taiwan Herbal Pharmacopeia or Chinese Pharmacopoeia.
In the event that the testing specifications set forth in the preceding paragraph are not listed in the Taiwan Herbal Pharmacopoeia or Chinese Pharmacopoeia or are not covered by any other foreign pharmacopoeias or announcements acknowledged by the central health authority, manufacturers and importers shall establish the testing specifications at their own discretion based on their actual needs.

The formulation basis of Chinese medicine shall be in compliance with any of the following regulations:
1. For the formulas included in the “Standard Formulas of Chinese Medicine” announced by the central health competent authority, the dosage form and formula contents shall be identical to those stated in the “Standard Formulas of Chinese Medicine”.
2. The formulas conform to those listed in well-established publications or any other publications recognized by the central health competent authority.
3. The formulas conform to those listed in the drug licenses held by other drug companies. However, formulas that are listed in the drug licenses issued by the Ministry of the Interior or renewed by the central health competent authority but not listed in any of the well-established publications shall not be used as the formulation basis.
4. In the case of export licenses, the formulas shall be included in the importing country’s pharmacopeia or standard formulas or shall meet purchase order requirements.
The well-established publications mentioned in Subparagraph 2 of the preceding paragraph refer to “Yi Zong Jin Jian (Golden Mirror of Medicine)”, “Yi Fang Ji Jie (Analytic Collection of Medical Formulas)”, “Ben Cao Gang Mu (Compendium of Materia Medica)”, “Ben Cao Gang Mu Shi Yi (Supplement to Compendium of Materia Medica)”, “Wai Ke Jheng Zhong (Orthodox Manual of External Disease)”, “Ben Cao Bei Yao (Essentials of Materia Medica)”,“Grand Dictionary of Chinese Medicine”, and “Chinese Materia Medica Grand Dictionary”.
The license number or publication title, edition number, and page numbers shall be indicated in the “formulation basis” field of a registration application form. A photocopy of the formulation basis shall be submitted.
The dosage form of products to be manufactured or imported shall be identical to the dosage form that is indicated in the formulation basis submitted in accordance with the preceding paragraph, except for the cases where the powder and capsule forms are interchangeable or where all forms of concentrated Chinese medicine preparations are interchangeable.

The name of a Chinese medicine product shall comply with the following regulations:
1. Single ingredient preparations: Products are named by adding the manufacturer’s name, brand name or trademark, and dosage form to the name of the Chinese medicine. If a merchandise name is used, then the name of the Chinese medicine shall be added to the end of the product name in brackets.
2. Compound preparations: Products are named by adding the manufacturer’s name, brand name or trademark, and dosage form to the compound name indicated in a pharmacopoeia. If a merchandise name is used, then the compound name indicated in a pharmacopoeia shall be added to the end of the product name in brackets.
If the name of a Chinese medicine product, as set forth in the preceding paragraph, is used for export only, the foregoing limitations shall not apply.

If a Chinese medicine product has a name that is used for export only or any of the following conditions occurs, and a photocopy of the purchase order placed by a company in the importing country and indicating the name that is used for export only, or a photocopy of the trademark registration certificate is submitted along with an application for registration, the manufacturer’s name may not be included in the product name:
1. The applicant is a proprietor of a registered trademark.
2. The applicant is not a proprietor of a registered trademark but a licensee of such a trademark. The proprietor of such a trademark is a manufacturer commissioned by the applicant to manufacture products. Moreover, a trademark license is submitted.
3. The applicant is not a proprietor of a registered trademark but a licensee of such a trademark. The proprietor of such a trademark is not a manufacturer commissioned by the applicant to manufacture products. Registration has been filed with the trademark authority, and a trademark license and registration documents have been submitted.

The name of a Chinese medicine product shall not contain the drug trademark or name of another manufacturer, unless the applicant has acquired the trademark rights to use the manufacturer’s name or has obtained a letter of consent from the commissioned manufacturer to use its name in the case of commissioning others to manufacture products.

A Chinese medicine product is named in Chinese or a foreign language:
1. Chinese: No combination with foreign letters or Arabic numerals is allowed, unless they directly convey a meaning.
2. Foreign languages: They may be translated from Chinese by means of transliteration or semantic translation.
Up to three product names, as set forth in the preceding paragraph, shall be provided for the central health competent authority to approve one of them.
Chinese medicine product names that are used for export only shall not be subject to the quantitative limitation set forth in the preceding paragraph if they are directly transliterated from Chinese. However, if such names are not directly transliterated from Chinese, no more than three names shall be approved for each application.

The merchandise name of a Chinese medicine product shall not be similar or identical to the merchandise name of any product of other drug companies, and shall not involve counterfeiting or insinuation.
If an applicant intends to name a new product after another of the applicant’s approved drugs with an annotation, then the annotation shall not cause inappropriate association or confusion between the original and annotated product names.

Chinese medicine with the same formula but in different sizes of pills, tablets, or capsules and excipients are made of different aromatics, coloring agents or flavors, shall have the same product name, provided that an identifiable name is added in brackets to the end of the product name. Medicines with the same formula but in different dosage forms may have different product names.
A drug company shall not give products with different formulas the same product name.

If the name of a Chinese medicine product involves the efficacy, the name shall be appropriate to the efficacy and indication. If necessary, clinical efficacy evaluation results shall be provided for justification.

The name of a Chinese medicine product shall not misrepresent or exaggerate the efficacy and safety of the product, cause inappropriate association or confusion in regard to the product name and efficacy, or encourage drug abuse.

In the case of an application for license transfer or the change of a product name or any inconsistency between the name of a Chinese medicine product and the provisions of the preceding seven articles, the central health competent authority may re-assess the product name.

The “packaging” field on the application form for Chinese medicine registration shall contain such information as quantity, materials, and types of packaging. The minimum packaging unit used for indicating the quantity shall be consistent with the dosage form unit stated on the application form for drug registration.
The weight of the packaging for Chinese medicated patches, as indicated on the labels, shall not include the weight of the films.

The maximum quantity for each packaging unit of Chinese medicine products is as follows:
1. Tablets, pills, and capsules: No more than 1000 units
2. Powders, granules, gels, ointments, and plasters: No more than 1000 grams
3. Liquid for internal use, liquid for external use, plasters for internal use, wines, and distillates: No more than 1000 milliliters
4. Flakes: No more than 1000 packs
5. Medicated patches: No more than 1000 pieces
The minimum packaging size for multiple-dose Chinese medicine products shall be the minimum two-day dosage for adults.
For the Chinese medicines concerned in applications for export only, for use by drug companies and food manufacturers as raw materials, or for use by medical institutions and academic organizations, the maximum or minimum packaging quantity shall not be subject to the limitations set forth in the preceding two paragraphs. However, for the products concerned in applications for use by medical institutions, the packaging quantity shall not exceed two times the maximum packaging quantity requirements. If the packaging quantity exceeds twice of the maximum packaging quantity, the certificate of purchase from the medical institutions shall also be attached.
Provided that the packaging of Chinese medicines conforms to the requirements set forth in the preceding three paragraphs, manufacturers may, at their own discretion, make adjustments to suit the market needs without filing an application for post-approval changes. If the packaging does not conform to the requirements set forth in the preceding three paragraphs, manufacturers are required to file an application for post-approval changes.

Information given in the “name of raw materials” and “contents” fields on the application form for Chinese medicine registration shall comply with the following regulations:
1. The name of raw materials shall be labeled in Chinese.
2. Chinese medicine materials shall be those listed in the “Ben Cao Gang Mu (Compendium of Materia Medica)”, “Taiwan Herbal Pharmacopoeia”, or other pharmacopoeias or medicine formularies acknowledged by the central health competent authority. Contents shall be indicated in metric measurements.
3. The full formula shall be listed in the order of monarch, minister, assistant, guide, and excipients. If the product adopts a standard formula announced by the central health competent authority, the list shall be made in the order consistent with that of the standard formula.
4. Units for labeling:
(1) Traditional tablets, pills, and capsules: The contents of each raw material shall be indicated in the minimum unit.
(2) Traditional powders, granules, gels, ointments, plasters, and medicated patches: The contents of each raw material shall be indicated per gram.
(3) Liquid, plasters for internal use, wines, and distillates: The contents of each raw material shall be indicated per milliliter.
(4) Flakes: The contents shall be indicated per pack.
(5) Concentrated Chinese medicine preparations: The contents of single ingredient preparations shall be indicated per gram, while those of compound preparations shall be indicated per daily dose. However, in the case of tablets, pills, and capsules, the contents of each raw material shall be indicated in the minimum unit.
5. Labeling on capsule shells:
(1) Soft capsules: A description of the full formula of soft capsules shall be provided.
(2) Hard capsules: The outer colors of the cap and body of hard capsules as well as the size number shall be indicated.
6. If any cold and cough preparations contain tea leaves, the maximum content of tea leaves per day shall be 3.75 grams.

Information filled in the “efficacy” or “indications” field on the application form for Chinese medicine registration shall comply with the following regulations:
1. For those using a standard formula announced by the central health competent authority as the formulation basis, the information shall be identical to the standard formula.
2. For those using a well-established publication as the formulation basis, the information shall be consistent with the contents of said publication.
3. For those using a formula listed in the drug license of another drug company as the formulation basis, the information shall be consistent with that in the drug license.
4. If clinical trials have been conducted, the information shall be consistent with the clinical trial reports that have been submitted for recording.

Information given in the “dosage and administration” field on the application form for Chinese medicine registration shall comply with the following regulations:
1. The dosage shall be proportional to the content of the original formula.
2. After conversion, the daily dose of Chinese medicine in concentrated form or liquid form (for internal use) shall be equivalent to that of Chinese medicine drinks; in principle, the daily dose is divided into 2-3 doses for administration.
3. Dosages for children: In principle, the dose for children between the ages of 8 and 15 is two-thirds of the dose for adults; the dose for children between the ages of 5 and 7 is half of the dose for adults; the dose for children between the ages of 2 and 4 is one-third of the dose for adults; or there shall be a label specifying that the dosage for children decreases with age.
Medication for infants under the age of 2 shall be decided by physicians after diagnosis and treatment. The label on OTC drugs shall not indicate the dosage and administration for infants under the age of 2.

The information contained on labels, package inserts, or packaging for Chinese medicine is subject to Article 75 of the Act. The contents and presentation shall comply with the following regulations, and the fonts shall be easy to read:
1. Package inserts shall contain information on drug category, packaging, storage conditions and other necessary information.
2. The information contained on package inserts is limited to the extent of the efficacy or indications. For compound preparations, the information is limited to the extent of the main pharmacological effects of their mixed active ingredients. Exaggerated terms and wordings are not allowed.
3. A detailed description of contraindications, warnings, side effects, and precautions shall be provided on the package inserts, and shall be printed in red or in bold with a different font or, when necessary, with a red frame.
4. For any Chinese medicine preparation that uses a merchandise name, the original formula name derived from a pharmacopeia shall be listed after the product name in the package inserts, or on the labels or outer boxes if no package inserts are provided.
5. Unless otherwise provided, the Chinese fonts printed on package inserts shall not be smaller than DFKai-SB font size seven.
6. Labels, package inserts, and packaging materials shall not include indecent or offensive images or wording or exaggerated descriptions of the efficacy and indications.
7. If a distributor’s name is printed on the labels, package inserts, or packaging materials, the distributor shall have obtained a business license, and the font size of the distributor’s name shall not be larger than that of the name of the manufacturer (license holder).
8. The font size of the Chinese product name shall not be smaller than that of any foreign letters. The font size of the Chinese product name shall not be lower than that of any foreign letters.
9. For the font size of the product name, no character is allowed to be less than half of the size of any other characters. However, the font size of the manufacturer’s name, merchandise name, and dosage form will not be compared with each other.
10. For OTC drugs, “OTC Drug” or “Class B OTC Drug” shall be printed in a significantly larger font on labels and packaging materials according to their categories. In the case of preparations for external use, “For External Use” shall be printed in red or in bold with a different font or, when necessary, with a red frame.
11. The labeling of the smallest unit for single use, which is given or sold in its original package with the outer box remaining intact, should be at least labeled indicating Chinese product name, manufacturer’s name, and license number on the circumstances of the immediate package does not have enough space to include all required information.
12. For drugs packed in aluminum blister foils, the Chinese product name, manufacturer’s name, and license number shall be printed on each sheet of foil. The same rule also applies to aluminum foil packets for refills used by medical institutions.
13. Labels, packaging, or aluminum foil packets for refills used by medical institutions shall contain information in any of the following formats:
(1) Batch number, manufacturing date, and effective period;
(2) Batch number and expiry date; or
(3) Batch number, manufacturing date and expiry date.
14. The manufacturing date or expiry date, as required in the preceding paragraph, shall be printed in year-month-day format. The manufacturing date, effective period, and expiry date shall be printed in a manner understandable to consumers.
15. In the case of imported drugs, such information as the importer’s name, address, license number, Chinese product name, and category may be provided on a sticker.
16. The process of labeling or attaching stickers is subject to the GMP regulations. For imported drugs, labels or stickers shall be properly attached by the original manufacturers. Alternatively, a GMP certified manufacturer or a GMP certified medical product distribution center in Taiwan might be commissioned in accordance with the Regulations for Medicament Contract Manufacture and Analysis to carry out the packaging and labeling or sticker attaching processes after drugs are imported into Taiwan. However, labels indicating the foreign manufacturer’s name and address shall be properly attached by the original manufacturer.
The package inserts, labels, stickers, outer boxes, aluminum blister foils, and other printed materials or drafts indicating the materials used, which conform to the regulations set forth in all subparagraphs of the preceding paragraph, shall be properly attached to the forms for sticking outer boxes, package inserts, and labels, as specified in Paragraph 2 of Article 3. However, the package insert is not required for any Chinese medicated patches with contents to be set forth in the preceding paragraph package insert fully indicated on the label or package.

The application for Chinese medicine registration shall pick up the drug license and proceed with drug testing as notified by the central health competent authority; the application for post-approval changes of Chinese medicine registration shall pick up the drug license or proceed with drug testing as notified by the central health competent authority.
Upon receipt of the aforesaid notice for picking up the drug license, the applicant shall, within three months, pay the fees and proceed with the following steps:
1. Two copies each of the forms for sticking outer boxes, package inserts, and labels that are printed properly shall be provided. For new drugs, three copies each shall be provided.
2. The originally approved copies of the forms for sticking outer boxes, package inserts, and labels shall be returned.
3. A photocopy of the drug license that was attached to the application shall be returned.
If the applicant is required to correct any mistakes contained on the labels, package inserts, packaging, or other related materials submitted for the purpose of picking up the license within a specified deadline, the applicant may pick up the license only after having made corrections within the deadline specified by the central health competent authority.
If the applicant applies for any other change after receipt of a notice for picking up the license, the fee for post-approval changes shall be paid again.
In the review of a drug license, the competent central health competent authority shall add a supplementary clause, stating that the medicine cannot be launched in the market until it receives the notice of passed the tests; after the drug license has been picked up, the applicant does not follow the regulations to proceed with drug testing, or the sample test results are not consistent with the contents of the application or are disqualified for other reasons, then the central health competent authority shall revoke the drug license and notify the applicant to return the drug license within a specified deadline.

After an applicant receives a drug testing notice as set forth in the first paragraph of the preceding article, the applicant shall pay the fees and submit three portions of raw materials and a drug sample test form before the deadline. The deadline for drug testing shall be within 30 days for domestic Chinese medicines and within three months for imported Chinese medicines.
When necessary, the central competent health authority may order the applicant to provide three portions of drug samples or an appropriate quantity of reference standards.
The three portions mentioned in the preceding two paragraphs shall refer to a quantity sufficient for carrying out three tests.
If the central competent health authority deems it necessary to re-test a tested Chinese medicine product, the applicant shall pay the fees again.
Article 29 shall apply mutatis mutandis to the matters that the applicant shall comply with when proceeding with drug testing.

If an applicant for the registration of imported Chinese medicines is required to apply for Chinese medicine samples before proceeding with drug testing in accordance with the preceding article, the applicant shall carry out customs clearance according to the quantity of the Chinese medicine samples, raw materials, and reference standards stated on the drug testing notice set forth in Paragraph 1 of Article 82 in addition to proceeding with drug testing in accordance with the preceding article. However, to ensure that the packaging remains intact, the applicant may request the customs office to release the medicines in a single complete package if the quantity of a single package of imported medicines exceeds the quantity required for testing.
The regulations of the preceding paragraph shall apply mutatis mutandis to the samples, their quantity, and the customs clearance procedures for the testing required for the application for post-approval changes of imported Chinese medicines.

In the event that an applicant fails to pay the fees, fill out and submit an application form, prepare all required materials, or meet the other requirements set forth in the Regulations and, subsequently, has to take corrective actions, the central health competent authority shall notify the applicant to make the corrections within three months.
If the applicant is not able to make corrections within the deadline, a written statement specifying the reasons shall be submitted before the expiration of the correction period to apply for an extension. The extended period is one month after the day following the expiration of the original correction period. Only one extension will be allowed. If the applicant fails to make corrections within the deadline, then the central health competent authority may reject the application based on the current materials available.

The review criteria for concentrated Chinese medicine preparations are as follows:
1. In principle, compounds shall be decocted in combination. Those whose original formula involves traditional pills or powders may be decocted separately. Donkey-hide gelatin, mirabilite, maltose, and others not suitable for adding into decocting shall not be decocted in combination with others.
2. Extracts of decocted medicines may be prepared with lactose or starch, as listed in the Chinese Pharmacopoeia, or with excipients that do not affect efficacy. If the original formulation basis involves traditional pills, non-boiled traditional powders, or other medicines approved by the central health competent authority, the extract may be prepared with Chinese medicine base powders.
3. The levels of microorganisms, heavy metals, and pesticide residues in concentrated Chinese medicine preparations shall be within the limits announced by the central health competent authority.
4. The ratio of extracts to excipients should be 1:1 in principle, with an upper limit of 1:3.
5. The ratio of crude drugs actually produced to extracts shall be up to 15% more or less than the figure specified in the application.
The quantitative method, specifications, and required materials for marker ingredients of concentrated Chinese medicine preparations shall be in compliance with the regulations announced by the central health competent authority.

If a Chinese medicine product contains any protected species listed in Appendix 2 of the Convention on International Trade in Endangered Species of Wild Fauna and Flora, the source of these ingredients shall be indicated.

The Assurance Statements (A) and (B), Assurance Statement for Export Only (C), and Affidavit of Loss (D), as stipulated in the Regulations, shall include the name and address of the company or firm signing such statements or affidavits, the name of the person in charge, and the date of signature, and shall be affixed with the signet or stamp that is the same as those on the application form. In the case of outsourced manufacturing, assurance statements or affidavits shall be signed by both parties.

For the purpose of applying for Chinese medicine registration or post-approval changes, the clinical trials conducted in Taiwan shall conform to the following regulations:
1. A manufacturer shall conduct clinical trials in Taiwan in accordance with the Regulations for Good Clinical Practice and other regulations announced by the central health competent authority.
2. Before conducting a clinical trial, a manufacturer shall submit an application form for drug clinical trials, a protocol, a summary, and the technical data announced by the central health competent authority for reviews by the said authority.
3. After an application is reviewed and approved by the central health competent authority, the manufacturer shall conduct a clinical trial based on the comments given. After completion of the clinical trial, the clinical trial report and results shall be submitted for recording. Any necessary changes in the clinical trial protocol may be done only after such changes have been approved.
4. Before the central health competent authority reviews the clinical trial report and results, grants its approval, and issues a letter regarding the recording of the report, no applications for registration or post-approval changes will be approved.

Unless otherwise provided in this Chapter, the authorization letter, FSC from the country of origin, batch record and manufacturing and controls standards, form for sticking changed licenses and certificates, references and research reports, the applicant field on the application form, and outsourced manufacturing and inspection shall be subject to Article 5, Article 6, Article 11, Article 12, Article 13, Paragraphs 1 and 3 of Article 16, and Article 23, respectively.
If any of the following conditions occurs, applications concerning Chinese medicine shall be rejected:
1. Any of the conditions listed in Article 25 occurs.
2. Another application is submitted for products with the same dosage form on the same formulation basis. However, this provision is not applicable to those made into different sizes of pills, tablets, or capsules, as well as excipients made of different aromatics, coloring agents or flavors.

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.

In the case of outsourced manufacturing, the application form for post-approval changes of Chinese medicine shall be signed by both parties.

The following documents and data are required for applications for registration of changes in the Chinese or English name of a Chinese medicine product:
1. 1. Application form for post-approval changes;
2. Original copy of the drug license;
3. Assurance Statement (A); if a trademark is used, a photocopy of the trademark registration certificate or approval letter shall be submitted;
4. 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;
5. 5. In the case of imported Chinese medicines, 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;

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.

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.

If a change in the formula of a Chinese medicine product involves changes of active ingredients, then the applicant shall re-apply for drug registration. However, the regulation shall not apply to cases of removing cinnabar or protected medical materials, cases based on standard formulas, or cases of proportional changes of other ingredients of a formula if applications for post-approval changes in excipients may be submitted in accordance with Paragraph 1 or 3 of the preceding article.

The following documents and data are required for post-approval changes in the indications, efficacy, administration, and dosage of a Chinese medicine product:
1. Application form for post-approval changes;
2. Original copy of the drug license; however, a photocopy is acceptable for applications for changes in administration and dosage;
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 the references that support the change.

The following documents and data are required for post-approval changes in the product or license category for a Chinese medicine product:
1. Application form for post-approval changes;
2. Original copy of the drug license;
3. Application form for drug review and registration;
4. 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;
5. Photocopy of the references that support the change.

In any of the following situations, manufacturers may, at their own discretion, change labels, package inserts, or packaging of domestically manufactured Chinese medicine preparations without any changes in the originally approved text:
1. Changing the graphic design or colors; however, the graphic design shall not be offensive, indecent, or misleading;
2. Proportionally resizing the originally approved graphic design or text, or repositioning the originally approved graphic design or text;
3. Changing the fonts; however, the font size of the English product name shall not be larger than that of the Chinese product name;
4. Adding or changing the symbol for the corporate identity system;
5. Printing labels on outer boxes instead of sticking labels on them;
6. Additionally providing outer boxes that display the same text and graphic design as those on the original labels.
In case of any of the following changes in the originally approved text without affecting drug quality or medication safety, manufacturers may, at their own discretion, change labels, package inserts, or packaging of domestically manufactured Chinese medicine preparations:
1. Adding or changing the barcode, NHI code, ID code, “GMP” wording, names of ingredients of the formula in foreign languages, copyright registration number, trademark registration certificate number, or patent certificate number;
2. Adding or changing the suggested retail price or the customer service hotline;
3. Changing the name or address of the drug company, or adding or changing the telephone number, fax number, and contacts;
4. Adding or changing the distributor’s name and address; the font size of the distributor’s name shall not be larger than that of the drug company’s name;
5. Adding or changing seal labels for outer boxes or price labels;
6. Adding “For use by XX Hospital or hospitals only; no resale is allowed” or similar wordings on the originally approved packaging;
7. Changing the manufacturer’s name that was added to the English product name;
8. Changing the measurement unit of formulas in order to comply with the Taiwan Herbal Pharmacopoeia; or
9. Changing the terms used in describing the storage methods without altering the original storage methods; the terms shall be consistent with those used in the Taiwan Herbal Pharmacopoeia or Chinese Pharmacopoeia.
If any changes in the text involves the addition of directions for use in order to ensure drug quality and medication safety, manufacturers may, at their own discretion, change labels, package inserts, or packaging of domestically manufactured Chinese medicine preparations.
For domestically manufactured Chinese medicine preparations to be exported, manufacturers may, at their own discretion, change the font of the product name, font of the distributor’s name, or the terms for storage method, or add an “export only” label, package insert, or packaging, without being subject to the restrictions set out in the provisos of Subparagraph 3 of Paragraph 1, and Subparagraphs 4 and 9 of Paragraph 2.
The changes or addition of an “export only” label, package insert, or packing set forth in the preceding four paragraphs shall conform to the Good Manufacturing Practices for Pharmaceuticals specified in the Pharmaceutical Good Manufacturing Practice Regulations, and records shall be made and retained by the manufacturers for recording purposes.

Except for the situations mentioned in the preceding article, a domestically manufactured Chinese medicine demanded for exporting which of any its “export only” label, package insert, or packing may be allowed to be changed without prior application and approval in any of the following circumstances where the originally approved text is changed without affecting the drug quality or medication safety:
1.Changing or deleting the manufacturer’s name or designation of the dosage form included in the product name;
2.The name of the Chinese medicine is changed to the approved name for “export-only” by the central health competent authority;
3.Changing the labeling method of the formula or deleting the excipient without changing the original formula proportion;
4.Deleting the domestic drug license number or adding license number approved by the destination country for export;
5.Changing or deleting the administration and dosage, but the changed administration and dosage shall not exceed the originally approved ones;
6.Deleting or simplifying the efficacy and indications;
7.Translating into a foreign language for the destination country for export;
8.Adding the trademark;
9.Adding precautions, warnings, or other text for ensuring drug quality and medication safety;
10.Other items as announced by the central health competent authority.
The changes or addition of an “export only” label, package insert, or packing set forth in the preceding paragraph shall conform to the Good Manufacturing Practices for Pharmaceuticals specified in the Pharmaceutical Good Manufacturing Practice Regulations, and records shall be made and retained by the manufacturers for future reference.

Except for the situations mentioned in the preceding two articles, applications for registration of changes in the packaging of Chinese medicine preparations shall comply with the following regulations:
1. The following documents and information are required for applications for changes in the maximum packaging size, provided that there are no changes in the packaging materials:
(1) Application form for post-approval changes;
(2) Original copy of the drug license.
2. The following documents and information are required for changes in the packaging materials:
(1) Application form for post-approval changes;
(2) Original copy of the drug license;
(3) Documentation procedures and reports of stability tests;
(4) Photocopy of batch records.
If the changes in the packaging materials mentioned in the preceding paragraph involve changes in labels, package inserts, or packaging, 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 shall also be submitted.
In case of imported Chinese medicine preparations, on top of the provisions in the two preceding 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.

Except for the situations described in the preceding article, the following information shall be submitted for application for change registration where domestically manufactured Chinese medicine preparations are making “export only” changes or adding “export only” drug name, maximum package quantity, packaging materials, efficacy, indications, administration and dosage, label, package insert, or packaging:
1.Application form for post-approval changes;
2.Assurance Statement for Export Only (C);
3.For changes in the drug name, maximum package quantity, packaging materials, efficacy or indications, the original copy of the drug license is required;
4.For changes in the administration and dosage, label, package insert, or packaging, the photocopy of the drug license (front and back) are required;
5.For changes in the drug name, the Assurance Statement (A) is required;
6.For changes in the packaging materials, photocopies of the documentation procedures and reports of stability tests, as well as the batch records are required;
7.For changes in the efficacy or indications of the drug, photocopy of the references that support changes is required;
8.For changes of the label, package insert, or packaging, two copies each of the forms for sticking outer box, package insert, and label are required.

The Assurance Statement (A) is required for applications for registration of outsourced manufacturing of Chinese medicine products and for applications for registration of self-manufacturing of products retrieved after outsourced manufacturing. Article 64 and Article 65 shall also apply mutatis mutandis respectively.
Article 66 applies mutatis mutandis to the outsourced inspection of Chinese medicine products.

Articles 47, 57, and 60 to 63 shall apply mutatis mutandis to post-approval changes in Chinese medicine licenses, including letters of notification of post-approval changes issued by the original manufacturer, changes in testing specifications and methods, changes in the name or address of the drug company (including the manufacturer), changes in labels, package inserts, outer boxes, and aluminum blister foils (packets), and the reissuance of the approved copies due to loss.

Articles 71 shall apply mutatis mutandis to the reissuance of lost licenses, and the replacement of damaged licenses.

The application for transferring a domestic Chinese medicine licenses should be filed by both parties. The following documents should be provided:
1. Application form for post-approval changes signed by both parties;
2. Original copy of the drug license to be transferred;
3. A list of drug licenses to be transferred, therein recording the license number, formula, dose and dosage form. However, the foregoing documents is not required for the application for transfer of a single drug license;
4. The assurance statement made by the transferee to certify the responsibility. For the transfer of the license of locally manufactured drugs, the assurance statement should also certify the absence of drugs of the same formula;
5. Photocopy of the transfer approvals issued by the health competent authorities of the local governments where the transferor and transferee are located;
6. An assurance statement (A);
7. A photocopy each of all changed certificates and licenses;
8. Manufacturing and Control Standard. This document can be exempted, if local manufacturers have no intention to initiate production at present.
The application for transferring an imported drug distributor’s license should be filed by both parties. The following documents should be provided:
1. Documents and data set forth in Subparagraphs 1 to 4 of the preceding paragraph.
2. Photocopy of the transfer approvals issued by the health competent authorities of the local governments where the transferor and transferee are located;
3. Original copy of the transfer agreement with signets of both parties;
4. Original copy of the authorization letter issued by the original manufacturer, stating the termination of the distributing contract with the transferor and the exchange of new contract with the transferee, as well as the addresses of both parties and the drug items involved in the transfer. The authorization letter should be authenticated by the R.O.C. foreign affairs offices;
5. A statement certifies that the same manufacturer does not have any products of the same formulation as the transferred drug.
For a product not yet manufactured as set forth in Subparagraph 8 of paragraph 1, the central health competent authority shall add the words “Manufacturing is prohibited” on the Chinese medicine license; if the manufacturer intends to actually produce the medicine subsequently, it should provide required documents and data under Subparagraph 1, 2 and 8 of paragraph 1 to approved by the competent central health competent authority before manufacturing.
When applying for domestic Chinese medicine licenses transfer, if the product name on the old license includes a prefix of the trademark or transferor’s company name which is not authorized, then an application for a change in product name should be filed at the same time.

Applications for a license extension shall be filed within six months prior to the expiration date.
If an application is not filed before the deadline set forth in the preceding paragraph, the applicant shall reapply for registration. However, if the applicant reapplies for registration within six months after the expiration of the original license, he/she may submit an original copy of the application form for registration and proceed in accordance with Article 109-1.
If an application for a license extension also involves post-approval changes, then a separate application shall be submitted.

The following documents and data are required for the applications set forth in Paragraph 1 of the preceding article:
1. Application form for a drug license extension, otherwise which shall be applied by the drug license holder on the circumstances of contract manufacturing;
2. Original copy of the drug license;
3. If the “expiration date” field on the drug license is filled with extension stamps, the original copy of the application form for drug registration is also required;
4. If the drug concerned is among those announced by the central health competent authority after it has conducted an evaluation in accordance with Article 48 of the Act, the documents required in the announcement shall be submitted for applications for extension;
5. If the manufacturing of the drug concerned is outsourced to a domestic manufacturer, a manufacturing outsourcing agreement shall also be submitted;
6. In the case of imported Chinese medicine, the original FSC from the country of origin, the authorization letter issued by the original manufacturer, and a photocopy of documents proving that the foreign manufacturer of imported medicines complies with the Good Manufacturing Practice for Medicinal Products are also required; if the applicant is not the holder of the documents proving the compliance with the Good Manufacturing Practice for Medicinal Products, the applicant may submit the authorization letter issued by the original manufacturer or the authorization letter issued by the domestic manufacturer that holds such documents and indicate the approval number instead.
For Chinese medicine listed in the Taiwan Herbal Pharmacopeia, the testing specifications and methods for finished products as well as a photocopy of the approval letter for the latest change of the Taiwan Herbal Pharmacopeia, shall be otherwise submitted. However, if the testing specifications meet or are better than the latest edition of the Taiwan Herbal Pharmacopeia, the testing specifications and methods for finished products may be adopted instead.
If any application for a license extension submitted involves concerns about the safety, efficacy, or indications of a product, the central health competent authority may request the applicant to submit relevant documents and data.