作为监管改革的一部分，一名受过北京教育的前美国联邦药物监管机构官员已被任命领导香港新的医疗产品机构，其任务是加速药物和医疗设备的临床使用。
A Beijing-educated former official at the US federal drug regulator has been appointed to lead Hong Kong’s new medical products body, tasked with accelerating the clinical use of medicines and medical devices as part of a regulatory overhaul.
政府于周一表示，曾在美国食品药品监督管理局（FDA）工作的李自力将自10月20日起出任卫生署辖下的医疗产品监管署长，任期三年。
Li Zili, who previously worked at the US Food and Drug Administration (FDA), would take up the post of controller for medical products regulation under the Department of Health on a three-year term beginning October 20, the government said on Monday.
他将领导将于今年晚些时候成立的医疗产品监管中心，该中心旨在推动积极主动的“原审批评”，加快药品和医疗设备的临床应用，并让患者使用符合质量和安全标准的前沿产品。
He will lead the Centre for Medical Products Regulation, to be established later this year, which aims to promote proactive “primary evaluation”, speed up the clinical application of drugs and medical devices, and give patients access to advanced products that meet quality and safety standards.
李自力曾在FDA两次任职，先是担任医疗团队负责人，后来担任该机构仿制药办公室的全球事务负责人。
Li served twice at the FDA, first as a medical team leader and later as head of global affairs at the agency’s Office of Generic Drugs.
香港卫生署署长林文健表示，他有信心李自力能够迅速且系统地建立该中心的监管能力。
Ronald Lam Man-kin, Hong Kong’s director of health, said he was confident Li could rapidly and systematically build the centre’s regulatory capability.
林文健表示：“李先生对国际医疗产品监管和公共卫生政策有深入的了解，在海外创新医疗产品的监管审查和独立评估方面拥有丰富的实操经验。他是一位有远见、有决心的杰出领导者。”
“Mr Li possesses an in-depth understanding of international medical product regulation and public health policy, as well as extensive hands-on experience in the regulatory review and independent evaluation of innovative medical products abroad. He is an outstanding leader with vision and determination,” Lam said.
李自力获得北京协和医学院医学学位，并在美国约翰斯·霍普金斯大学完成住院医师培训，还在此获得了公共卫生硕士学位。
Li earned his medical degree from Peking Union Medical College and completed his residency training at Johns Hopkins University in the United States, where he also obtained a Master of Public Health.
作为一名拥有美国行医执照的医师和国际公认的医疗高管，李自力在药物监管和全球药物研发方面拥有30多年的经验。
A US-licensed physician and internationally recognised medical executive, Li has more than 30 years of experience in pharmaceutical regulation and global drug development.
他还曾在多家跨国制药公司担任高级职务，包括担任强生公司旗下杨森制药公司的全球副总裁兼亚太区研发负责人。
He has also held senior roles at several multinational pharmaceutical companies, including as global vice-president and head of Asia-Pacific research and development at Janssen Pharmaceutical Companies of Johnson & Johnson.
李自力是药物信息协会的资深会员和董事会成员。2013年，他获得当时中国国家食品药品监督管理局药品审评中心颁发的监管科学特别贡献奖，随后于2014年获得美国FDA颁发的特别表彰奖，以表彰他对建立监管能力所做出的贡献。
Li is a fellow and board member of the Drug Information Association. In 2013, he received a Special Contribution Award in Regulatory Science from the Centre for Drug Evaluation of the then China Food and Drug Administration, followed by a special recognition award from the US FDA in 2014 for his contributions to building regulatory capacity.