Hong Kong appoints former US FDA official Li Zili as drug and device regulator
Hong Kong has appointed Li Zili, a former senior US FDA official, as its new drug and medical device regulatory director for three years from October 20. The role supports the city's new first-tier approval system ahead of the centre's launch this year.
Hong Kong has completed a global recruitment exercise and appointed Li Zili as director of drug and medical device regulation under the Department of Health, the government announced on Monday. His three-year term begins on October 20.
The Centre for Drug and Medical Device Regulation will be established within this year to promote a more proactive "first-tier approval" process, aimed at speeding up the clinical application of pharmaceuticals and medical devices.
Li obtained his medical degree from Peking Union Medical College and completed residency training at Johns Hopkins University in the United States, where he also earned a master's degree in public health. He is a licensed physician in the US and an internationally recognised healthcare management expert with more than 30 years of experience in drug regulation and global pharmaceutical development. He served twice at the US Food and Drug Administration (FDA), first as a clinical review supervisor and later as head of global affairs for generic drugs.
Director of Health Dr Ronald Lam said he was pleased to have found a suitable candidate for this important position. Lam described Li as having a deep understanding of international drug and device regulation and public health policy, with valuable hands-on experience in the regulation and independent evaluation of innovative overseas medical products.
"He is an outstanding leader with vision and drive. I am confident he will lead the team to rapidly and systematically build the regulatory capacity of the centre and strengthen the first-tier approval system," Lam said.
Lam noted that Hong Kong's first five-year plan calls for comprehensive reform of drug and device regulation, alignment with international standards, and building independent review and approval capabilities. The policy address also proposes accelerating the development of an international medical innovation hub and improving the pharmaceutical and device supply chain, in line with the nation's strategy to develop biomedical and medical device industries. The establishment of the centre marks a significant milestone in the city's regulatory reform.
