HK sets sights on drug and medical device regulatory authority

Hong Kong is striving to become an internationally recognised regulatory authority for pharmaceuticals and medical devices.

The new head of the Centre for Medical Products Regulation says the city's focus should be on the approval of rare disease drugs and advanced therapeutic medical products.

As the newly appointed controller for medical products regulation under the Department of Health Li Zili met the press, he shares his vision towards the Centre for Medical Products Regulation to be set up later this year.

Li says we need to build a regulatory agency with comprehensive capabilities and trust internationally while leveraging Hong Kong's unique strategic position in pharmaceutical regulation not only to serve patients in Hong Kong but also patients around the world.

The target is for Hong Kong to become an internationally recognised pharmaceutical and medical device regulatory authority on par with the mainland and the United States.

By 2030, they aim to have primary approvals for all drugs and devices without having to rely on certifications from other places. Having worked at the US Food and Drug Administration and educated in Beijing, Li believes Hong Kong should not be turned into a mini version of any other region's regulatory body.

In the future, it can focus on approving treatments for rare diseases and advanced therapeutic medical products because these two areas are newer fields with greater international divergence. As for whether approval times can be accelerated further, he says product quality must also be taken into consideration.

Director of Health Ronald Lam adds that Li stood out among 20 applicants in the global open recruitment drive. with his relevant practical experience that will help spearhead Hong Kong into an international medical innovation hub. Ronald Lam says in addition to transferring over 400 existing personnel from the department to the upcoming regulatory office, about 30 talents from both local and overseas markets will also be recruited.