Regulations for Registration of Medicinal Products Article 36
The Stability study, in support of the application for drug registration should comply with the following regulations:1.The stability study should include research on the drug degradation curve in order to estimate the period of efficacy and to ensure the effectiveness and safety of drugs in use. The study should be conducted in accordance with the Guidelines on the Drug Stability Study as announced by the central health competent authority.2.A stability study protocol and a report should be submitted.3.In order to ensure the sufficiency and completeness of a stability study, the applicant should provide any supplementary or necessary information upon the central health competent authority’s request. However, the applicant may retain the original data of a stability study for future inspection. No submission of such data is required.4.In principle, the stability study of toll-manufactured drugs should be conducted to ensure drug quality. It can be conducted by (but not limited to) manufacturers involved in the toll-manufacturing process.
中文原文 藥品查驗登記審查準則第36條
申請查驗登記須執行之藥品安定性試驗，規定如下：
一、執行安定性試驗，應研究出藥品退化曲線，據以推定有效期間，確保藥品使用時之有效性及安全性，並符合中央衛生主管機關公告之藥品安定性試驗基準。
二、執行安定性試驗，應提出安定性試驗書面作業程序及其報告。
三、為確認安定性試驗之充足與完整，申請人應依中央衛生主管機關之通知，補充其他相關或必要資料。
但藥品查驗登記申請案件，有關安定性試驗報告之原始數據紀錄得免送審而留廠商備查。
四、分段委託製造之藥品，其安定性試驗之執行，以能確認藥品品質為原則，不限由分段委託製造製程之受託製造廠執行。
一、執行安定性試驗，應研究出藥品退化曲線，據以推定有效期間，確保藥品使用時之有效性及安全性，並符合中央衛生主管機關公告之藥品安定性試驗基準。
二、執行安定性試驗，應提出安定性試驗書面作業程序及其報告。
三、為確認安定性試驗之充足與完整，申請人應依中央衛生主管機關之通知，補充其他相關或必要資料。
但藥品查驗登記申請案件，有關安定性試驗報告之原始數據紀錄得免送審而留廠商備查。
四、分段委託製造之藥品，其安定性試驗之執行，以能確認藥品品質為原則，不限由分段委託製造製程之受託製造廠執行。