Pharmaceutical Affairs Act Article 39

For the manufacture or import of drugs, information concerning the ingredients, sources of active pharmaceutical ingredients, specifications, functions, summaries of the manufacturing process, specifications, and analytical methods, 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 manufacture or import shall be allowed until such approval is granted and a drug license is issued.Provisions of the preceding paragraph do not apply to an application to the central competent health authority for the importation of active pharmaceutical ingredients for trial manufacturing. Said application criteria and application fee shall be determined by the central competent health authority.Only the drug license holder or their authorized persons may apply for the import of drugs pursuant to the provisions of the first paragraph.For the application for registration and market approval referred to in the first paragraph, change or transfer of registration of a drug license in accordance with Article 46, issuance of extension, replacement, or re-issuance of a drug license in accordance with Article 47, the application criteria, review procedure, approval criteria, and other matters to be complied with shall be established in the Regulations for Registration of Medicinal Products by the central competent health authority.