HK to launch Centre for Medical Products Regulation, overhauling drug and device oversight

The government has outlined legislative proposals to establish the Hong Kong Centre for Medical Products Regulation, including transferring regulatory powers over both Chinese and Western medicines to the Director of Health, with plans to present the bill to the Legislative Council in the second half of this year. 

In documents submitted to the Legislative Council, the Health Bureau emphasized that the new center, set up under the Department of Health, will position Hong Kong to actively participate in international cooperation on pharmaceutical and medical device regulation.

It will revise the current separate ordinances that regulate Western medicines and Chinese medicines and transfer drug regulatory powers to the Director of Health to streamline the regulatory framework and align it with international standards.  

The new center will perform related functions to enhance overall regulatory consistency and efficiency, allowing swifter responses to the development of innovative drugs and devices in support of national policies promoting new-quality productivity in pharmaceuticals and medical devices.

Authorities believe these amendments will improve operational consistency between the Chinese and Western medical regulatory systems while addressing existing overlaps in their institutional structures.

The Health Bureau also proposed setting up a new Chinese Medicine Appeal Tribunal under the Chinese Medicine Ordinance dedicated to handling appeals against regulatory decisions on Chinese medicine and related traders, including disciplinary rulings. 

Parties who are dissatisfied with the tribunal’s decisions will have the right to appeal further to the Court of First Instance.

Looking ahead, the government will continue to explore a comprehensive revision of both the Pharmacy and Poisons Ordinance and the Chinese Medicine Ordinance. It will also seek further improvements to the existing drug regulatory regime and will consult with relevant stakeholders on these future arrangements.