Regulations for Registration of Medicinal Products Article 89
For the purpose of applying for Chinese medicine registration or post-approval changes, the clinical trials conducted in Taiwan shall conform to the following regulations:1. A manufacturer shall conduct clinical trials in Taiwan in accordance with the Regulations for Good Clinical Practice and other regulations announced by the central health competent authority.2. Before conducting a clinical trial, a manufacturer shall submit an application form for drug clinical trials, a protocol, a summary, and the technical data announced by the central health competent authority for reviews by the said authority.3. After an application is reviewed and approved by the central health competent authority, the manufacturer shall conduct a clinical trial based on the comments given. After completion of the clinical trial, the clinical trial report and results shall be submitted for recording. Any necessary changes in the clinical trial protocol may be done only after such changes have been approved.4. Before the central health competent authority reviews the clinical trial report and results, grants its approval, and issues a letter regarding the recording of the report, no applications for registration or post-approval changes will be approved.
中文原文 藥品查驗登記審查準則第89條
申請中藥查驗登記或變更登記，其進行國內臨床試驗之規定如下：
一、藥商進行國內臨床試驗，應符合藥品優良臨床試驗準則及中央衛生主管機關公告之規定。
二、藥商進行臨床試驗前，應提出藥品臨床試驗申請書、計畫書、內容摘要表及中央衛生主管機關公告之技術性資料，送交中央衛生主管機關審查。
三、中央衛生主管機關審查同意後，藥商應依審查意見所載事項，進行臨床試驗，並於試驗完成後，將試驗報告結果送交備查；其臨床試驗計畫有變更必要時，應申請核准變更後，始得進行。
四、試驗報告結果未經中央衛生主管機關審查核准，並發給報告備查函之前，其查驗登記或變更登記申請案不予核准。
一、藥商進行國內臨床試驗，應符合藥品優良臨床試驗準則及中央衛生主管機關公告之規定。
二、藥商進行臨床試驗前，應提出藥品臨床試驗申請書、計畫書、內容摘要表及中央衛生主管機關公告之技術性資料，送交中央衛生主管機關審查。
三、中央衛生主管機關審查同意後，藥商應依審查意見所載事項，進行臨床試驗，並於試驗完成後，將試驗報告結果送交備查；其臨床試驗計畫有變更必要時，應申請核准變更後，始得進行。
四、試驗報告結果未經中央衛生主管機關審查核准，並發給報告備查函之前，其查驗登記或變更登記申請案不予核准。