Policy Address

Healthy Hong Kong

Develop into a Health and Medical Innovation Hub – Establish a Drug Approval Authority based on "Primary Evaluation" in the Long Run

139. With our high-quality medical care services and efficient healthcare system, Hong Kong is among the places with the longest life expectancy in the world. We are determined to leverage Hong Kong's medical strengths with the long-term objective of establishing an authority that registers drugs and medical devices under the "primary evaluation" approach, i.e. to directly approve applications for registration of drugs and medical devices based on clinical data, without relying on other drug regulatory authorities. We will endeavour to attract more pharmaceutical and medical device enterprises, both locally and from around the world, to conduct R&D and clinical trials in Hong Kong, and build up the capacity, recognition and status to ensure that the eventual approval mechanism of drugs and medical devices of Hong Kong would be widely recognised internationally and by the Mainland. We will:

  1. set up a preparatory office for the Hong Kong Centre for Medical Products Regulation (CMPR) – A preparatory office will be set up to study the potential restructuring and strengthening of the current regulatory and approval regimes for medicine, medical devices and medical technology. The office will also put forward proposals and steps for the establishment of the CMPR which will be a step towards the transition to the "primary evaluation" approach in approving applications for registration of pharmaceutical products, and explore the upgrading of the CMPR as a standalone statutory body in the long run. This will help accelerate the launching of new drugs and medical devices to the market, and foster the development of R&D and testing of medical products and related industries;

  2. accession to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) – We will pursue Hong Kong, China's accession to ICH as an observer to familiarise with and promote the latest development of drug regulation, and to pave the way for developing Hong Kong into an internationally recognised regulatory authority for drugs and medical devices in the long run;