Regulations for Registration of Medicinal Products Article 22-1
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.
中文原文 藥品查驗登記審查準則第22-1條
下列藥品除已於我國進行對國人用藥安全性及有效性具代表性之臨床試驗，且能提供東亞人種之藥物動力學資料者外，應申請銜接性試驗評估：
一、新成分新藥及屬新成分之生物藥品。
二、其他經中央衛生主管機關公告應申請銜接性試驗評估之藥品。
經中央衛生主管機關認定符合小兒或少數嚴重疾病藥品審查認定要點、細胞治療及基因治療製劑者，免申請前項銜接性試驗評估。
申請銜接性試驗評估，應填具銜接性試驗評估查檢表，並附藥品之完整臨床試驗數據資料（completeclinicaldatapackage），且宜含東亞人種資料。
銜接性試驗評估，得於查驗登記前提出申請、或與查驗登記申請案同時申請。
經中央衛生主管機關評估認定得免除銜接性試驗者，其查驗登記申請案，得免附銜接性試驗資料。
但其藥品之療效與安全性，仍應有充足之臨床試驗資料為依據。
如經評估認定不得免除銜接性試驗者，申請人應依評估結果，擬定適當之銜接性試驗計畫書送交中央衛生主管機關審查。
俟審查同意後，申請人應執行銜接性試驗，並於試驗完成後，將試驗報告及相關資料送交中央衛生主管機關備查。
於國內完成銜接性試驗並經本署核准之新藥，自發證日起五年內，凡製造或輸入相同成分、劑型、劑量之學名藥廠商，除依現行規定檢附資料外，應另檢附與申請新藥查驗登記且經本署首先核發許可證廠商相同標準之國內銜接性試驗報告。
一、新成分新藥及屬新成分之生物藥品。
二、其他經中央衛生主管機關公告應申請銜接性試驗評估之藥品。
經中央衛生主管機關認定符合小兒或少數嚴重疾病藥品審查認定要點、細胞治療及基因治療製劑者，免申請前項銜接性試驗評估。
申請銜接性試驗評估，應填具銜接性試驗評估查檢表，並附藥品之完整臨床試驗數據資料（completeclinicaldatapackage），且宜含東亞人種資料。
銜接性試驗評估，得於查驗登記前提出申請、或與查驗登記申請案同時申請。
經中央衛生主管機關評估認定得免除銜接性試驗者，其查驗登記申請案，得免附銜接性試驗資料。
但其藥品之療效與安全性，仍應有充足之臨床試驗資料為依據。
如經評估認定不得免除銜接性試驗者，申請人應依評估結果，擬定適當之銜接性試驗計畫書送交中央衛生主管機關審查。
俟審查同意後，申請人應執行銜接性試驗，並於試驗完成後，將試驗報告及相關資料送交中央衛生主管機關備查。
於國內完成銜接性試驗並經本署核准之新藥，自發證日起五年內，凡製造或輸入相同成分、劑型、劑量之學名藥廠商，除依現行規定檢附資料外，應另檢附與申請新藥查驗登記且經本署首先核發許可證廠商相同標準之國內銜接性試驗報告。