关键词: 临床急需进口港澳药品, 临床急需进口港澳医疗器械, 多医疗机构申请的伦理审查, 伦理审查, 共识

Abstract: To standardize the ethical review process of the “Hong Kong and Macao Drugs and Medical Devices Access” in Guangzhou,meet the clinical demand for drugs and medical devices,and ensure the safety of patients’ use of drugs and medical devices,the Medical Ethics Branch of Guangzhou Medical Association and the“Hong Kong and Macao Drugs and Medical Devices Access”Professional Committee of Guangzhou Hospital Association organized industry experts,combined with relevant policy and regulatory requirements and local practical experience,widely solicited expert opinions,the “Consensus on Ethical Review of Drugs and Medical Devices for Hong Kong and Macao in Guangzhou” were formed after several discussions．The consensus content covers aspects such as the scope of application,terms and definitions,principles of ethical review,categories of ethical review,procedures of ethical review,methods of ethical review,and Ethical Review for Multi-institutional Applications．The consensus aims to provide guidance for the ethical review work of designated medical institutions for the “Hong Kong and Macao Drugs and Medical Devices Access” in the Guangzhou area,unify the review standards,improve the efficiency and quality of the review,effectively protect the legitimate rights and interests of patients,promote the safe and rational use of clinically urgently imported medicines and medical devices Hong Kong Macao,and thereby promote the development of medical and health care in the Guangdong-Hong Kong-Macao Greater Bay Area．

Key words: Clinically Urgently Imported Medicines from Hong Kong and Macao, Clinically Urgently Imported Medical Devices from Hong Kong and Macao, Ethical Review for Multi-institutional Applications, ethical review, consensus