Regulations for Registration of Medicinal Products｜第 4 條｜Food and Drug Administration｜Regulation｜In Force
第 二 章/第 一 節｜衛生福利部｜v1.0
Effective Date: 2024-01-01｜Last Amended: 2023-04-27
The terms used in this chapter are defined as follows: 1.New drugs: the new drugs described in Article 7 of the Pharmaceutical Affairs Act. 2.Generic drugs: pharmaceutical preparations identical to a drug already approved in Taiwan in the aspects of ingredients, dosage form, contents and efficacy. 3.Bio-pharmaceuticals: serum, antitoxin, vaccines, toxic, bacteria sap and products manufactured based on the theories of microbiology and immunology. 4.Substances (Active pharmaceutical ingredients): An active substance or ingredient manufactured through physical and chemical processes or bio-tech procedures and with pharmacological effects that are often used for the manufacturing of drugs, bio-pharmaceuticals or bio-tech products. 5.Radiopharmaceutical drugs: drugs meeting the definition given in Article 6, containing radioactive substances for human uses. After being administrated to humans, the drug can diagnose, monitor, treat, alleviate disease conditions or achieve other medical effects.