Regulations for Registration of Medicinal Products Article 38-4
NCE drug applications with the submission of two or more CPPs issued by the A10 countries should comply with regulations set out in Article 39 and 22-1. If necessary, the central health competent authority may request the submission of a Post-Approval Risk Management Plan.
中文原文 藥品查驗登記審查準則第38-4條
申請新成分新藥查驗登記，如檢附十大醫藥先進國家二國以上之採用證明者，除依第三十九條規定外，仍需依第二十二條之一規定辦理。
必要時，中央衛生主管機關得要求檢附上市後風險管理計畫。
必要時，中央衛生主管機關得要求檢附上市後風險管理計畫。