The Department of Health today announced that the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has formally accepted Hong Kong, China as its observer.

The department described the news as an important step for Hong Kong in moving towards the establishment of a registration mechanism of drugs and medical devices based on "primary evaluation" in the long run.

Delighted by such positive news, Secretary for Health Prof Lo Chung-mau said the Hong Kong Special Administrative Region Government is taking progressive steps to bloom from the current “secondary evaluation” approach towards the establishment of a “primary evaluation” approval mechanism recognised internationally and by the Mainland.

In that event, approval of drugs, medical devices and technologies in Hong Kong will no longer rely on the approval from other reference drug regulatory authorities but directly base on supporting clinical data and expert advices, Prof Lo said.

This would enable patients to get early access to new drugs, while attracting more local, Mainland and overseas pharmaceutical and medical device enterprises to conduct research and development and clinical trials in Hong Kong, he added.

Prof Lo stressed that taking such progressive steps would lead to gradually building up the capacity, recognition and status of the approval mechanism of drugs and medical devices of the city to ensure the eventual mechanism would be widely recognised by the Mainland and internationally.

“To this end, a series of key initiatives were announced in the ‘Chief Executive’s 2023 Policy Address’. Following the implementation of the ‘1+’ mechanism for registration of new drugs on November 1, another initiative is the accession of Hong Kong, China to the ICH as an observer so that we can get familiarised with the latest development of drug regulation and take forward the development of the drug regulatory system in Hong Kong.

“This would also enable us to become more on par with the World Health Organization-Listed Authority, paving the way for developing Hong Kong into an internationally recognised regulatory authority for drugs and medical devices in the long run."

The health chief expressed gratitude to the National Health Commission and the National Medical Products Administration for fully supporting Hong Kong, China in the application for accession to the ICH as an observer, as well as their support and guidance in the work of drug approval in Hong Kong.

He also thanked the Department of Health for its extensive work in making this happen, including sending delegates to the Czech Republic to introduce the work and stringent standards in drug approval and regulation at the ICH Assembly.

The ICH is an internationally recognised association. It currently has 15 regulatory members comprising drug regulatory authorities from Mainland China, Europe, Switzerland, the UK and the US, where "primary evaluation" approach is adopted.

The Hong Kong SAR Government said the accession to ICH as an observer will lay the foundation for it to advance the implementation of the ICH guidelines in Hong Kong so as to strengthen the local capacity of drug approval as well as facilitate software, hardware and manpower development, with becoming an ICH regulatory member as the ultimate goal.