Regulations for Registration of Medicinal Products Article 94
The following documents and data are required for applications for the registration of new Chinese medicine:1. The registration application form and other documents;2. Domestic clinical trial reports;3. Technical data required by the central health competent authority as listed in official announcements.In the event that the clinical trial report is difficult to conduct by local clinical trials, supporting data applicable to the Taiwanese people may be otherwise submitted for the application of adoption of foreign clinical trial data, which may be recognized only upon the approval by the competent central health competent authority.
中文原文 藥品查驗登記審查準則第94條
申請中藥新藥查驗登記，應檢附下列文件、資料：
一、查驗登記申請資料。
二、國內臨床試驗報告。
三、中央衛生主管機關公告之技術性資料。
前項臨床試驗報告，於國內執行臨床試驗窒礙難行者，得另檢送足以外推適應至我國族群之佐證資料，申請以國外臨床試驗數據替代之，並經中央衛生主管機關審查同意後，始得採認。
一、查驗登記申請資料。
二、國內臨床試驗報告。
三、中央衛生主管機關公告之技術性資料。
前項臨床試驗報告，於國內執行臨床試驗窒礙難行者，得另檢送足以外推適應至我國族群之佐證資料，申請以國外臨床試驗數據替代之，並經中央衛生主管機關審查同意後，始得採認。