China-educated ex-US FDA official to lead Hong Kong’s medical products regulator

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.

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.

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.

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.

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.

“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.

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.

A US-licensed physician and internationally recognised medical executive, Li has more than 30 years of experience in pharmaceutical regulation and global drug development.

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.

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.