Login / Register

Market OpportunitiesTech & InnovationEntrepreneurshipSustainabilityCreativity & LifestyleHKTDC Updates

My Feed

Market Opportunities

Healthtech innovation accelerates


Hong Kong reforms regulatory approach to fast track drug and medical device development.


Hong Kong is quickly developing into one of the world’s leading innovation hubs, with healthtech and biotech at the forefront.

To further leverage Hong Kong’s medical strengths, the Hong Kong SAR Government is establishing the Hong Kong Centre for Medical Products Regulation (CMPR) to accelerate the launch of new drugs and medical devices to the market and foster the development of R&D and testing of medical products and related industries.

The long-term objective is to create an internationally recognised regulatory authority that registers drugs and medical devices under the primary evaluation approach.

At the opening of the fourth Asia Summit on Global Health in May, organised by the Hong Kong Trade Development Council (HKTDC), Hong Kong SAR Chief Executive John Lee highlighted this initiative: “To expedite the registration of new drugs, our new “1+” mechanism came into effect last November. The mechanism allows for the registration of specific new drugs that are supported with local clinical data, with the approval from only one reference drug regulatory authority. It will attract more drug development in Hong Kong and increase clinical trials here.”

Prof Lo Chung-mau, Hong Kong SAR Secretary for Health, told the event audience that the city had just renewed the cooperation agreement on drug recognition with Mainland China’s National Medical Products Administration, which will cooperate extensively with CMPR once established.

Hong Kong has also joined International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as an observer. This will further enhance the city’s regulatory regime following the launch of the “1+” mechanism.

Prof Lo pointed out that the Hospital Authority in Hong Kong will enhance its Drug Formulary to accelerate approval for new treatments. This – along with enabling designated healthcare institutions in mainland cities in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) to use Hong Kong-registered drugs and medical devices – will help streamline the approval process for drugs.

The GBA’s ability to rapidly translate biomedical innovation into products through the industry chain makes the GBA the ideal venue for healthtech development.

Hong Kong and Shenzhen are boosting efforts to coordinate clinical development and trials in order to seize these advantages.

This will include setting up the GBA International Clinical Trial Institute in the Hetao Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone to provide a one-stop clinical trial support platform for medical research institutions.

The Institute will coordinate clinical trial resources in the public and private healthcare sectors in Hong Kong, including researchers, supporting services, data banks, sample banks, laboratories.

It will also leverage the advantages of both Hong Kong and Shenzhen and work to national and international standards.

Furthermore, Hong Kong’s Hospital Authority will help medical professionals conduct clinical research by setting up a clinical research office at its headquarters.

Noting Hong Kong’s record for successful healthcare outcomes – it boasts the longest life-expectancy in the world – the Legislative Council Panel on Health Services in February this year published a paper setting out the path for the city to become a global leader in healthcare research and regulation.

The paper set out many of the steps discussed at ASGH. Additional proposals included establishing the CMPR as a statutory body and for Hong Kong to become a regulatory member of the ICH to enhance international recognition for drugs approved in the special administrative region.

Discover More

Subscribe free e-newsletter

Latest on Asia business intelligence
Mobile-friendly design to read on the go
Customise your news by registering online

Learn about latest market updates and insights to empower your business.