Regulations for Registration of Medicinal Products｜第 22-1 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
Except for drugs with relevant local clinical trial data to justify drug efficacy and safety in Taiwan, alone with pharmacokinetic data on ethnic groups in East Asia, the following drug items are subject to a bridging study assessment: 1.New chemical entities and new biologics; 2. Items announced by the central health competent authority as requiring a bridging study assessment. Drugs received designations of treatment of pediatric or rare severe disease from the central health competent authority, cellular and gene therapy products are exempted from the bridging study assessment. When applying for a bridging study assessment, manufacturers should fill out the checklist for bridging study assessments and provide a complete clinical data package, preferably with data on ethnic groups in East Asia. Applications of bridging study assessments can be filed prior to or together with the applications of drug registration. Bridging study data would not be required for the applications of drug registration that have been approved by the central health competent authority to be exempt from bridging studies. However, there should still be sufficient clinical data to justify drug efficacy and safety. If the assessment result suggests that a bridging study is necessary, the applicant should prepare an appropriate protocol according to the comments from the assessment and submit the protocol to the central health competent authority for assessment. After the protocol is approved, the applicant should conduct the bridging study and submit study reports and related data to the central health competent authority for inspection. In situation where a license is granted to a new drug with the submission of bridging study data, if in the next 5 years any generic manufacturer intends to manufacture or import generics with ingredients, dosage form and contents identical to this new drug, then the generic manufacturer should submit all required data and a bridging study report up to the standards set by the first license holder.