Government appoints Controller for Medical Products Regulation
The Government announced today (October 12) that, following a global open recruitment exercise, Mr Li Zili will take up the appointment as the Controller for Medical Products Regulation under the Department of Health (DH) for a three-year term with effect from October 20, 2026. The Centre for Medical Products Regulation (CMPR) will be set up in 2026 to promote proactive "primary evaluation", accelerate the clinical application of drugs and medical devices (medical products) and enable patients to access state-of-the-art medical products that meet the requirements of quality and safety.
"As set out in the First Five-Year Plan for Economic and Social Development of the Hong Kong Special Administrative Region (2026-2030), Hong Kong will comprehensively intensify the regulatory reform of medical products, enhance our regulatory regime to align with international standards, develop the capacity for independent evaluation and approval of medical products, and participate actively in international regulation of medical products to pursue recognition from international authorities. The Chief Executive's 2026 Policy Address also announced that, to dovetail with our country's strategic development of the emerging industries of biomedicine and medical devices, Hong Kong will accelerate the development of an international health and medical innovation hub and progressively optimise the innovative medical products industry chain. The establishment of the CMPR marks a significant milestone in the Hong Kong Special Administrative Region (HKSAR)'s reform of medical products evaluation, approval and regulatory system. It is also an indispensable factor for advancing the registration, regulation and research and development of medical products. The HKSAR Government will offer a world-class and modern regulatory environment to support the approval for innovative medical products and expedite their clinical application, thereby driving medical innovation and contributing to the global health industry internationally. We will comprehensively and proactively align with the National 15th Five-Year Plan, fully leveraging Hong Kong's distinctive advantages of enjoying the strong support of the motherland and being closely connected to the world under the 'one country, two systems' principle, thereby jointly contributing to propelling the national strategy of 'Healthy China'," the Director of Health, Dr Ronald Lam, said.
"Through a global open recruitment process, we are pleased to have successfully identified a suitable candidate for the key position of the Controller for Medical Products Regulation. Mr Li possesses an in-depth understanding of the international regulation of medical products and public health policies, and has extensive and valuable hands-on experience in regulatory and independent evaluation of innovative medical products abroad. He is an outstanding leader with vision and determination. I am confident that he can lead the team to rapidly and systematically establish the CMPR's regulatory capability, strengthen primary evaluation capacity, enhance international credibility and connectivity of the CMPR, and position the CMPR as an authoritative, reliable, distinctive medical products regulator that promotes medical innovation and public health," Dr Lam added.
Brief biographical notes of Mr Li are set out below:
Mr Li obtained a degree in medicine from the Peking Union Medical College, completed his residency training at the Johns Hopkins University in the United States (US) and holds a Master of Public Health degree from the Johns Hopkins University. He is a US-licensed physician and internationally recognised medical executive with more than 30 years of profound experience in pharmaceutical regulation and global drug development.
He previously served twice at the US Food and Drug Administration (FDA) as a Medical Team Leader and later as Head of Global Affairs at Office of Generic Drugs.
Mr Li also spent a significant part of his professional career leading clinical development and regulatory strategy across several multinational pharmaceutical companies, including serving as Global Vice President and Head of Asia-Pacific R&D at Janssen Pharmaceutical Companies of Johnson & Johnson.
He is also a fellow and a member of the Board of Directors of the Drug Information Association, a leading global multidisciplinary life science membership association bringing together regulators, industry, academia and other stakeholders across drug, device and diagnostic development.
Mr Li received a Special Contribution Award in Regulatory Science from the Center for Drug Evaluation of the then China Food and Drug Administration (CFDA) in 2013 and a special recognition award from the US FDA in 2014, in recognition of his contributions to building regulatory capacity and capability. He was also one of the key contributors to the CFDA's accession to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use in 2017.
Government appoints Controller for Medical Products Regulation Source: HKSAR Government Press Releases
