• Regulations for Registration of Medicinal Products

In accordance with Article 39, 46 and 47 of the Pharmaceutical Affairs Act, the manufacturing and import of drugs 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 license is approved and issued. The official approval is required for any change, transfer or extension of drug license. The application criteria, review procedure, approval criteria, and other matters to be complied with shall be established in the Regulations for Registration of Medicinal Product by the central competent health authority. Considering that the Regulations for Registration of Medicinal Product is established for enhancing medication safety of the public, the competent authority issuing, changing or extending the drug license and, the companies and industries who manufacture or import drugs shall all comply with the regulation.