The Regulations are established pursuant to Article 39 Item 4 of the Pharmaceutical Affairs Act (hereafter the Act).

The registration of drugs, and the post-approval change, transfer, extension, or reissue of damaged or lost drug licenses should follow the Regulations. Matters not included in the Regulations are subject to other regulations, orders or announcements made by the central health competent authority.

For the registration items mentioned in the preceding article, the applicant should pay the application fees and submit completed application forms and all required dossiers to the central health competent authority for assessment.
The above-mentioned application forms and documents include those for drug review and registration, post-approval changes, extension of validity of drug license, assurance statement, sticking label and package insert, sticking licenses and certificates, and other forms and documents in relation to the application procedure.
“Chinese language” in the Regulations denotes traditional Chinese. For forms and documents requiring Chinese language, please provide information in traditional Chinese characters or documents with translations in traditional Chinese characters.
The license holder may retain the original certificates for future inspection when submitting an application via the electronic submission platform an electronic system, but needs to submit the original drug license to the central health competent authority to have the approval status marked on the license.