眾律國際法律事務所

眾律國際法律事務所 專利工程師暨法務專員林春宏

美國柏克萊加州大學 分子生物學士

美國柏克萊加州大學 資訊管理 碩士

加拿大英屬哥倫比亞大學 法律博士

2012-12-13

Pharmaceutical Affairs Act : Registration and Market Approval of Drugs in Taiwan

In Taiwan, the Pharmaceutical Affairs Act is the primary legislation for regulating drugs and medical devices. To be able to import and sell drugs in Taiwan, drug companies must obtain registration and market approval from the Food and Drug Administration of the Department of Health, which is a department under the Executive Yuan of Taiwan.

Chapter IV of the Pharmaceutical Affairs Act deals with the registration and market approval of drugs in Taiwan.

More specifically, Article 39 stipulates:

“For the manufacturing and import of drugs, information concerning the 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.”

Chapter IX of the Pharmaceutical Affairs Act includes the penal provisions for those who violate the Act. For example, Article 83 states:

“Any person who knowingly sells, supplies, dispenses, transports, stores, brokers, transfers or displays with intent to sell counterfeit drugs or prohibited drugs shall be punished with imprisonment of not more than seven (7) years and may, in addition thereto, be imposed with a fine of not more than NT$5,000,000.

Any person engaging in violations referred to in the preceding Paragraph as their major source of income shall be sentenced to a term of imprisonment between two years and ten years, in addition thereto, be subject to a fine of no more than NT$25,000,000.”

References:

Food and Drug Administration of the Department of Health (Taiwan)

http://www.fda.gov.tw/TC/law.aspx?cid=68&cchk=5de8311e-df71-4c43-b741-4a65701ba76e

http://www.fda.gov.tw/EN/law.aspx?cid=166&cchk=ffadc9f0-ce81-4849-84dd-cfe41809095d