特定藥品專案核准製造及輸入辦法

These regulations are promulgated pursuant to the Paragraph 3 of Article 48-2 of the Pharmaceutical Affairs Act (hereafter “the Act”).

1Teaching hospitals which are higher level than regional hospital or psychiatric teaching hospitals may submit the following documents when applying to the central competence authority for approval of specific medicinal products’ manufacturing or importing as a special case in accordance with Subparagraph 1 of Paragraph 1 of Article 48-2 of the Act:

21. Diagnosis certificate;

32. Verification of the approval of the application for the specific medicinal products from the IRB of the submission hospital;

43. A complete therapy protocol and related references;

54. The patient's informed consent form;

65. The amounts of the medicinal products and the calculation basis;

76. Instructions of the medicinal products; and

87. Medicinal products' certificates of the market approval or a photocopy of the reference country’s pharmacopeia.

9Contents in Subparagraph 1 and Subparagraph 2 of preceding Paragraph shall include the intention that it is for the purpose of prevention, diagnosed as life-threatening, severely disability diseases, and there is no domestic appropriate drug or alternative treatment. Whereas the drug applying in accordance with Paragraph 1 and cannot submit documents listed in Subparagraph 7 of Paragraph 1, it shall submit product's manufacturing and quality control documents, the animal safety test report, human body usage data and risk-benefit assessment report as the substitution.

1Centers for Disease Control or pharmaceutical firms may submit the following documents when applying to the central competence authority for approval of specific medicinal products’ manufacturing or importing as a special case in accordance with Subparagraph 2 of Paragraph 1 of Article 48-2 of the Act:

21. A complete prevention or therapy protocol.

32. Related science evidence or references to show the benefits will greater than the risks.

43. Instructions of the drug.

54. The drug's certificates of the market approval in foreign countries or a photocopy of the reference country’s pharmacopeia; and

65. Treatment plan in the event of severe adverse reaction.

7Contents in Subparagraph 1 of preceding Paragraph shall include the application purpose of responding the emergency public health circumstances; for imported drugs, shall include the amounts of the drug and the calculation basis.

8The term “severe adverse reaction” contents in Subparagraph 5 of Paragraph 1 shall refer to Regulations for Reporting Severe Adverse Reactions of Medicaments’s Article 4.

1While the central competence authority reviews the application in accordance with the preceding two articles, shall take the situation, risk and benefit, and amounts calculation methods listed in Paragraph 1 of Article 48-2 of the Act into consideration. When approved, it may be with additional conditions imposed.

2While the central competence authority make the decision of approval or disapproval may consult with scholars or professionals or convenes an expert review meeting when necessary, and may publicize the scholars and expert opinions or conference related information or medical products’ approval assessment report, but the authority shall keep in confidence any trade secrets.

1The central competent authority may approve the validity duration of the specific medicinal products' manufacturing or importing in accordance with Article 2, based on the situation of individual case.

2The central competent authority may approve the validity duration no more than two years of the specific medicinal products' manufacturing or importing in accordance with Article 3. Where it is necessary to continue the manufacturing or importation of the specific medicinal products' upon permit license expiration, applications for license extension should be filed within three months prior to the expiration date.

3Application for the above extension can be submitted in accordance with Articles 3.

The medicinal products approved in accordance with Article 3, in the case that changes have to be made to an approved item, the changes must be approved before execution.

1The manufacturing or importing of the specific medicinal products which are approved in accordance with this regulation, the applicant shall continue to conduct safety and medical efficacy assessment after the approval. The manufacturing or importing of the specific medicinal products approved in accordance with Article 3, the delivery and its sales objects should be recorded.

2If necessary, the central competent authority may order the applicant to submit the assessment or record of preceding paragraph within a time limit.

1The specific medicinal products’ manufacturing or importing which are approved in accordance with this regulation, with any of the following circumstances, shall be deemed with a doubt of safety or medical efficacy as prescribed in subparagraph 3 Paragraph 2 of Article 48-2 of the Act, the central competent authority may annual the approval:

21. Additional conditions are not implemented.

32. Applicant did not submit the assessment and record within the time limit of the preceding article, or failed to make corrections within the deadline after the submission.

These regulations shall be effective as of the date of promulgation.