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Enforcement Rules of the Rare Diseases and Orphan Drugs Act
Formulated and announced under Wei-Shu-Pao Order No. 0890009921 on August 9, 2000

Article 1. This set of Rules is formulated in accordance with the regulations of Article 35 of the Rare Diseases and Orphan Drugs Act (hereafter referred to as the Act).

Article 2. Items and indications for the special nutrient foods essential to the maintenance of life of patients of rare diseases mentioned in the Act shall be announced by the central competent authority.

Article 3. The disease prevalence mentioned in Paragraph 1, Article 3 of the Act, refers to the year-prevalence calculated by the central competent authority with reference to the information reported by medical personnel in accordance with the regulations of Article 7 of the Act and information of medical care under the National Health Insurance.
The Central competent authority shall review every three years the criteria of announcement of the above-mentioned disease prevalence.

Article 4. The special circumstances mentioned in Paragraph 1, Article 3 of the Act, refer to disease prevalence that exceeds the criteria of announcement of the central competent authority, or the prevalence is difficult to calculate, and that the methods and pharmaceuticals for diagnosis and treatment are indeed difficult to obtain, and that these facts are recognized by the Committee for the Review and Examination of Rare Diseases and Orphan Drugs set up by the central competent authority in accordance with the regulations of Article 4 of this Act.

Article 5. Medical personnel charged with the responsibility of reporting in accordance with the regulations of Article 7 of this Act, shall within a month after the detection of patients or human remains of rare diseases, report to the central competent authority.

Article 6. The central competent authority shall include in statistical reports demographic changes of the population of rare diseases.

Article 7. The genetic health counseling centers mentioned in Article 8 of the Act refer to medical care institutions entrusted by the central competent authority to conduct prevention, research, and genetic health counseling services on genetic rare diseases.

Article 8. The central and the municipal competent authorities in organizing and holding educational activities for the prevention and control of rare diseases in accordance with the regulations of Article 11 of the Act, shall formulate plans in coordination with education, social affairs and information competent authorities and perform the plans accordingly.

Article 9. Institutions assisted by the central competent authority for international medical cooperation programs in accordance with the regulations of Paragraph 1, Article 13 of the Act, the central competent authority may subsidize them in accordance with the reimbursement criteria regulated for the self-paid medical costs of emergency medical care of injuries and diseases under the National Health Insurance.

Article 10. Similar medical product mentioned in Paragraph 1 and Paragraph 2, Article 17 of the Act, refers to the following:
1. The active substance(s) and the indication(s) are the same as the chemical drug previously issued permit license upon registration and market approval in accordance with this Act.
2. The principal molecular structural features and the indication(s) are the same as the biological or macromolecular product previously issued permit license upon registration and market approval in accordance with this Act.

Article 11. The right-holders of orphan drugs mentioned in Subparagraph 1, Paragraph 1, Article 18 of this Act, refer to persons who own permit licenses of the orphan drugs.

Article 12. Applicants for registration and market approval to the central competent authority in accordance with the regulations of Subparagraph 2, Paragraph 1, Article 18 of the Act, shall submit documents to prove that the safety or efficacy of the new orphan drugs under application is superior to the orphan drugs already approved.

Article 13. The failure to meet demands for the drugs mentioned in Subparagraph 3, Paragraph 1, Article 18 of the Act, refers to the failure of the right-holders in supplying in sufficient amount pharmaceuticals of the rare diseases and who have been notified by the central competent authority to correct in due time and have not made improvement yet.

Article 14. When the central competent authority is considering the reasonableness of prices of orphan drugs in accordance with the regulations of Subparagraph 4, Paragraph 1, Article 18 of the Act, shall consult the price analysis information supplied by new applicants and right-holders, price references announced by the Bureau of National Health Insurance and other information.

Article 15. Forms for this Act and this set of Rules shall be decided by the central competent authority.

Article 16. This set of Rules shall be implemented on August 9, 2000.
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Modify Dete:2016/11/07 Publish Date:2016/11/07