Regulations for Good Clinical Practice Article 58
The sponsor, or other owners of the data, shall retain all of the sponsor-specific essential documents pertaining to the trial for at least 2 years after approval of the marketing application of the investigational product(s) in Taiwan. However, these documents shall be retained for a longer period if required by other applicable regulatory requirements.
中文原文 藥品優良臨床試驗作業準則第58條
試驗委託者或其他數據所有者，應保存所有試驗委託者應負責與試驗相關之必要文件，至試驗藥品於我國核准上市後至少二年。
但其他法規規定之保存期間長於二年者，從其規定。
但其他法規規定之保存期間長於二年者，從其規定。