关键词: 药品, 医疗器械, 紧急授权, 突发事件

Abstract: From the point of the urgent R&D and review requirement of drugs and devices for COVID-19， we found that there are problems in the special approval system of medical products， then pointed out that lack the basis in the upper laws for emergency authorization system， and the urgent authorization pathway should be established beyond the conventional pathway. We suggested that emergency authorization articles should be included in the regulations of the implementation of the drug administration law and the supervision of medical devices. The drug regulatory department under the State Council shall formulate the measures for emergency authorization of drugs and medical devices， and make provisions for the scope of products， review departments， review procedures， submission materials， responsibility exemption， etc.

Key words: Drugs, Medical devices, Emergency use authorization, Emergency events