For the manufacturing and import of drugs, information concerning the ingredients, source of active pharmaceutical ingredients, specifications, functions, summary of manufacturing process, and the specification and method of testing, as well as other related information and certificates, accompanied by labels and use instructions in the original and Chinese languages, and samples, together with the fee paid, shall be filed with the central competent health authority for registration and market approval. No manufacturing or importation of such drugs shall be allowed until a drug permit license is approved and issued.
Provisions of the preceding Paragraph shall not apply to application to the central competent health authority for importation of raw materials for the manufacturing. Said application criteria and application fee shall be determined by the central competent health authority.
Only the owners of a drug permit license or their authorized persons may apply for import of drugs pursuant to the provisions of the first Paragraph. Application for change or transfer of registration of drug permit license obtained as per for registration and market approval the first Paragraph shall be conducted in accordance with the provisions under Article 46; the issuance of extension of registration, replacement, or new permit license shall be conducted in accordance with the provisions under Article 47. The application criteria, review procedure, approval criteria, and other matters to be complied with shall be established in the Criteria Governing the Review for Registration and Market Approval of Drugs by the central competent health authority.

For the manufacturing and import of medical devices, an application together with fees paid, shall be filed with the central competent health authority for registration and market approval. No manufacturing and importation shall be allowed until a medical device permit license is approved and issued.
Only the owners of a medical device permit license or their authorized persons may apply for import of medical devices pursuant to the provisions of the preceding Paragraph.
The application criteria, review procedure, approval criteria, and other matters to be complied with for the application, for registration and market approval, change, transfer, extension, replacement, and new issuance of medical devices permit license shall be established by the central health competent authority.

For the public benefit, the Central Competent Health Authority may, if necessary, publicize the drug substances, package insert, or relevant information, which are supplied by pharmaceutical firms in their application for manufacturing or importing medicaments and thus held and kept by such Health Authority The Health Authority shall keep in confidence any trade secrets in the new drugs application which are under evaluation before registration.
The Central Competent Health Authority shall enact measures governing the extent and method of the publication authorized by the preceding Paragraph.

1. Upon the issuance of a new drug permit, the Central Competent Health Authority shall publish the patent numbers or file numbers [that have already been] disclosed [to the public] as submitted by the applicant [for such new drug permit].
2. Within 3 years after the issuance of a license for new drug of a new molecular entity, no other pharmaceutical firm may apply for registration of the same drug by citing the application data submitted by said drug permit holder without such holder’s consent.
3. Starting from the next day to the expiration of the period stipulated in Paragraph 2 hereof, other pharmaceutical firms may apply for registration of drugs in accordance with this Act and relevant regulations; for those in compliance with relevant regulations, the Central Competent Health Authority may issue a drug permit only after the next day to the expiration of the 5-year period after the issuance of said new drug permit of new molecular entity as stipulated in Paragraph 2 hereof.
4. Paragraph 2 hereof is applicable only when an application for registration of a drug containing a new molecular entity is filed with the Central Competent Health Authority within 3 years after marketing approval is obtained for such drug in any country.

1. For a drug that has been approved by the Central Competent Health Authority to supplement or amend the indications thereof, within 2 years after the approval of such supplements or amendments to indications, no other pharmaceutical firm may apply for registration of the same indication by citing the application data submitted by said drug permit holder without such holder’s consent.
2. Starting from the next day to the expiration of the period stipulated in Paragraph 1 hereof, other pharmaceutical firms may apply for registration of drugs in accordance with this Act and relevant regulations; for those in compliance with relevant regulations, the Central Competent Health Authority may issue drug permit only after the next day to the expiration of the 3-year period after the approval of supplements or amendments to indications as stipulated in Paragraph 1 hereof. However, if the holder of drug permit obtaining the approval of supplements or amendments to indications conducts a domestic clinical trial regarding such supplements or amendments to indications, the Central Competent Health Authority may issue a drug permit to other pharmaceutical firms only after the next day to the expiration of a 5-year period after the approval of supplements or amendments to indications.
3. Paragraph 1 hereof is applicable only when an application for registration of such supplements or amendments to drug indications is filed with the Central Competent Health Authority within 2 years after such approval of indications is obtained for such drug in any country.

In order to improve the pharmaceutical manufacturing standard and the quality of clinical trial, and to dedicate in research and development of pharmaceutical technology, the central competent health authority shall entrust professional medical groups to conduct educational training programs to cultivate talents in skills of clinical trial every year.
The research and development of emerging pharmaceutical technology may be encouraged by the central competent health authority and the central competent industrial authority.
The rules of required qualification, reviewing procedure and other matters of compliance for encouragement under the preceding paragraph shall be established by central competent health authority and central competent industrial authority

The central competent health authority shall establish operational guidelines as standards for issuing, changing, and extending drug permit licenses in regard to the manufacturing and import of drugs.
The operational guidelines referred to in the preceding Paragraph shall be established by the central competent health authority.

Application forms to be used for filing application for registration and market approval of medicaments manufactured or imported, quantities of samples and relevant information required, and registration fees shall be established by the central competent health authority.

Medicaments for trial may be supplied to approved teaching hospitals for use in clinical trials to confirm the safety and therapeutic efficacy thereof only after obtaining an approval from the central competent health authority.

The central competent health authority may set a specific period of time for monitoring the safety of new drugs approved for manufacturing or import. The central competent health authority shall establish matters that the pharmaceutical dealers shall adhere to during the safety monitoring period referred to in the preceding Paragraph.

Medical care institutions, pharmacies, and pharmaceutical dealers shall report any serious adverse reactions caused by medicaments. Regulations regarding method, content, and matters to be complied with shall be established by the central competent health authority.

Without approval of the central competent health authority, no alteration may be made to any of the originally registered particulars pertaining to any medicament approved for manufacturing or importation.
Transfer registration shall be required in case a medicament manufacturing or import permit license is to be transferred.

A medicament manufacturing or import permit license shall be valid for five (5) years. Where it is necessary to continue the manufacturing or importation of medicament upon permit license expiration, the permit license may be extended with a prior approval of the central competent health authority provided that the term of each extension be limited to no more than five (5) years. The permit license shall be revoked upon expiry of the term thereof, if the permit license holder fails to file application for extension or if the application for extension is disapproved.
In case a permit license set forth in the preceding Paragraph is stained, damaged or lost, an application specifying the cause shall be filed with the original issuing authority for replacement; the original permit license shall be revoked, or through a public notice by the issuing authority.

When the central competent health authority upon re-evaluation, and doubts on safety or therapeutic efficacy of medicaments still in their valid period of manufacturing or importation, may order pharmaceutical dealers for correction in time. If correction is not made in time, their permit license may be revoked. Where the question of the safety is serious, the central competent health authority may revoke the permit license directly.

The manufactured or imported medicaments referred to in Paragraph 1 of Article 39, shall only be sold, wholesaled, retailed after labels, use instructions, or package of said medicament are indicated in Chinese. However, this shall not apply for those determined by the central competent health authority to cause undue hardship.

If any of the following circumstances applies, the central competent health authority may approve to manufacture and import the specific drug as a special case and is not subjected to Article 39 and Article 40:
1. For the purpose of prevention, diagnosed as life-threatening, severely disablility diseases, and there is no domestic appropriate drug or alternative treatment.
2. In responding to the necessity of emergency public health circumstances.
If any of the following circumstances applies, the central competent health authority may annul the approvement in the preceding Paragraph, shall order the applicants to handle the unused drug in a limit of time, and may make an announcement for recall.
1. When a drug is completed with registration and market approval, or there is a appropriate treatment to support the necessity of circumstance prescribed in Subparagraph 1 of the preceding Paragraph.
2. The emergency public health circumstance has been terminated.
3. Drug reviewed by the central competent health authority but has been designated with a doubt of safety or medical efficacy.
The application eligibility, reviewing procedure, approvement criteria, and other requirement regulations of the approvement as a special case in the first paragrah shall be established by the central competent health authority.