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Hong Kong Chief Executive Proposes Plans to Establish Drug Regulatory Authority

Updated: 6 days ago

Chief John Lee Ka-chiu stated today (11th) in an interview on RTHK's program "Policy Review" that Hong Kong's professional standing in the medical field has not yet been fully leveraged. If advantages can be combined with the mainland in clinical trials, it will yield significant results with less effort.


Lee emphasized that many medical scholars in Hong Kong are world authorities but have not focused sufficiently on utilizing their professional status. He mentioned that reform is a current priority. The government’s long-term goal is to establish its own drug regulatory authority capable of approving drugs and medical devices. To achieve this goal, a dedicated office is needed to prepare, including joining international organizations and strengthening clinical research.


Lo Chung-mau met with National Medical Products Administration
Lo Chung-mau met with National Medical Products Administration

He pointed out that Hong Kong and the mainland can work together to leverage their strengths in clinical trials, such as using mainland data, which includes a patient database of 1.4 billion people or nearly 80 million people in the Greater Bay Area. By conducting top-tier clinical trials, pharmaceutical companies can be attracted to Hong Kong, thereby increasing the region's competitiveness and business opportunities.


Regarding the establishment of a third medical school in Hong Kong, Lee expressed that he does not want the three medical schools to compete for students. The current idea is that students at the third medical school should ideally already hold a degree. In addition to becoming doctors, graduates should also have the opportunity to engage in research, which will significantly contribute to the long-term development of medical professionalism in Hong Kong. He also noted that more than one university is interested, and each university has its advantages. Ultimately, a working group will assess which university is most suitable, and the program must meet the standards set by the Medical Council for graduates to be licensed as doctors.


In the interview, he outlined a blueprint for the development of the healthcare sector, including the long-term goal of establishing its own drug regulatory authority to approve drugs and medical devices. To achieve this goal, the government needs to set up a relevant office to prepare for this initiative.


Additionally, Hong Kong should join relevant international organizations and strengthen clinical research.


Regarding clinical research, he hopes that Hong Kong can collaborate with mainland China to leverage advantages in clinical trials, such as utilizing the patient database of 1.4 billion people in mainland China or nearly 80 million people in the Greater Bay Area. This would enable the conduct of top-tier clinical trials, thereby attracting overseas pharmaceutical companies to Hong Kong and increasing the region's competitiveness and business opportunities.


In July of this year, the Secretary for Food and Health, Sophia Chan, mentioned that they are considering whether to establish a regulatory authority similar to the U.S. Food and Drug Administration (FDA) to directly approve drugs for market entry, in order to attract more pharmaceutical companies to conduct research and clinical trials locally, thus propelling Hong Kong to become a regional biomedical hub.


Generally speaking, under the current mechanism, new drugs and cancer medications must be registered in other countries, such as those in Europe and the U.S., before they can undergo a second layer of approval in Hong Kong. If Hong Kong successfully establishes a drug regulatory authority, it will no longer need to wait for foreign approvals and will be able to independently process drug applications.


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