The Department of Health today announced that the Hong Kong Centre for Medical Products Regulation (CMPR) will be established by the end of 2026.
Additionally, the department will implement “primary evaluation” for new drug registration in phases starting next year, with full implementation by 2030.
At a press conference this morning, Director of Health Dr Ronald Lam said with the CMPR’s establishment, the Government will consolidate the regulatory functions for Western and Chinese medicines as well as medical devices, and enhance the existing regulatory regime in a holistic manner.
“The vision of the CMPR is to become a ‘leading, internationally renowned medical products regulatory authority, driving excellence and innovation’, with the goal of gaining international recognition in the field.
“The CMPR will promote innovation, and research and development of drugs and devices by optimising medical products regulation.
“This will ensure that the public can benefit from the latest scientific research, and that patients will gain earlier access to innovative, safe and effective medical products. It also fosters growth in the local healthcare and biotechnology industries.”
The department established the Preparatory Office for CMPR in June last year. Since then, preparatory work has been focusing on driving regulatory excellence, promoting medical product innovation, and deepening national and international collaboration.
As for the implementation of “primary evaluation”, Dr Lam noted that the Government implemented the “1+” mechanism in November 2023, an important step towards the adoption of “primary evaluation”.
Under the “1+” mechanism, new drugs that are supported by local clinical data and recognised by relevant experts can be applied for registration in Hong Kong, if the applicant provides approval from the drug regulatory authority of one of the reference places, instead of two in the past.
Since its implementation, 11 new drugs have been approved for registration under this mechanism.
The initial phases of “primary evaluation” will cover applications for the registration of products containing registered chemical entities and biological entities with extended applications, such as new indications, new strengths, new posology and new dosage forms.
This will progressively establish a robust approval system, providing strong momentum for the development and market expansion of the healthcare industry in the city, the Mainland, and beyond, Dr Lam added.
