Hong Kong appoints Li Zili to lead new medical device and drug regulatory center

Li Zili has officially assumed the role of Director of the newly established Medical Device and Drug Regulatory Center under the Hong Kong Department of Health. Li emphasized that the center does not aim to be a “miniature version” of any existing international regulatory body, such as the FDA, but will instead focus on scientific, rigorous regulation to protect public health and promote medical innovation.

The center is designed to leverage Hong Kong’s unique position as a “super connector” between mainland China and the international community. By utilizing Hong Kong’s international reputation and the “1+” mechanism, the center aims to assist mainland China’s innovative drugs and medical devices in reaching global markets. Li noted that with 34% of the global new drug R&D pipeline originating from China, the center can help bring affordable “Me-too drugs”—which share mechanisms with existing drugs but have different structures—to patients without waiting for patent expirations.

To support these goals, the Department of Health is expanding its workforce. The center will establish a multidisciplinary scientific review team covering fields such as biomedicine, pharmacology, and statistics. Plans include adding approximately 30 professional positions, with some staff being recruited through contract arrangements if necessary.