The upcoming establishment of the Centre for Medical Products Regulation (CMPR) — which has been given a boost with the recent appointment of its inaugural head — marks a significant milestone in Hong Kong’s push for biomedical innovation.
For decades, Hong Kong has nurtured world-class scientific research, top-tier clinical talent, and a vibrant capital market. Yet, a critical institutional piece of the puzzle remained missing: an independent, internationally trusted local medical products evaluation authority. Following the establishment of the CMPR, with Dr Zili Li — a seasoned veteran with deep global regulatory experience spanning the United States’ Food and Drug Administration and multinational pharmaceutical companies — taking the helm as its inaugural controller, Hong Kong’s long-cherished vision of building a “local FDA” will firmly transition from a policy blueprint to an operational reality. Once the CMPR is formally established later this year, it is expected to transition Hong Kong toward an independent “primary evaluation” system, meaning the city will assess new drugs and medical devices based on raw clinical data rather than relying on approval certificates from secondary overseas authorities.
In recent years, China’s pharmaceutical sector has undergone a seismic shift, evolving from a generics-focused market into an innovation powerhouse. Chinese mainland biotech companies are producing breakthrough therapies in oncology, cell and gene therapy, and precision medicine at an unprecedented pace, increasingly out-licensing innovative assets to global pharma giants. However, taking domestic innovation to the global stage requires navigating a complex labyrinth of international clinical, quality, and regulatory standards.
This is precisely where Hong Kong’s unmatched positioning as a superconnector comes into play. Operating under the “one country, two systems” framework, Hong Kong combines a common law legal system, robust intellectual property protection, and alignment with international gold standards such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the Pharmaceutical Inspection Co-operation Scheme, with deep, organic ties to the mainland.
The CMPR is a critical chess piece in the nation’s strategy to scale the domestic biomedical industry and establish the Guangdong-Hong Kong-Macao Greater Bay Area as a world-class healthcare hub. Specifically, the establishment of the CMPR sets in motion Hong Kong’s historic evolution from a passive regulatory “follower”, historically reliant on overseas approvals, toward an active rule-maker and shaper of international medical governance. In other words, it will mark a foundational shift in how medical innovation is governed in the city. Its significance spreads across two main levels: transforming the city from a passive regulatory follower into an independent standard-setter, and acting as the gateway for the broader Chinese biopharmaceutical sector to enter the global market.
To turn this potential into reality, the SAR government envisions a clear, phased strategic road map to be implemented by the CMPR. In its initial phase, the CMPR can adopt a “small yet exquisite, phased, and priority-first” strategy, focusing first on high-need, high-potential domains such as rare diseases, advanced oncology drugs, cell and gene therapies, high-end medical devices, as well as pioneering Hong Kong standards for botanical medicines and herbal innovations to lead global regulatory harmonization in traditional medicine. By introducing early scientific advice and transparent pre-submission consultation mechanisms, CMPR can bridge the gap between strict statutory review and efficient industry enablement, ensuring innovators avoid costly detours.
Looking further ahead, the vision for Hong Kong’s regulatory evolution spans two critical horizons: Within the next five years, the CMPR aims to establish itself as a premier regional regulatory hub, actively pioneering mutual recognition, regulatory trust, and collaborative reviews with the Association of Southeast Asian Nations and Belt and Road Initiative-participating economies. Over the next decade, by deeply integrating into global regulatory frameworks through advanced regulatory science and international benchmarking, the CMPR aspires to stand shoulder-to-shoulder with global heavyweights like the FDA and the European Medicines Agency.
Furthermore, Hong Kong’s regulatory framework does not exist in a vacuum; it is powerfully amplified by the Greater Bay Area. By synergizing Hong Kong’s clinical excellence and international data compliance with the massive patient pools, manufacturing capabilities, and clinical trial infrastructure of mainland cities in the Greater Bay Area, enterprises can seamlessly execute multi-center trials and generate robust real-world data that satisfies both national and international bodies.
The establishment of the CMPR is expected to catapult Hong Kong’s biomedical innovation drive into a fast trajectory. With visionary execution and steadfast institutional reform, Hong Kong is well-prepared to write a brilliant new chapter in global healthcare and biotechnology.
The author is president of the HK Bio-Med Innotech Association.
The views do not necessarily reflect those of China Daily.
