Гонконг переходит к независимой системе одобрения лекарств для развития биотехнологий

Independent drug approvals are key to Hong Kong’s biotech ambitions Moving to a primary evaluation system will let the city directly approve innovative drugs based on local and international trial data This shift from a traditional secondary evaluation model – which until recently stipulated prior independent approvals from two external authorities – towards an independent, primary framework is integral to the city’s socio-economic goals. For decades, Hong Kong’s status as a world-class medical hub has been undisputed, yet its dependence on external regulatory approval meant local patients faced delays in accessing cutting-edge treatments. Transitioning to a primary evaluation system will enable the city to directly approve innovative drugs based on local and international clinical trial data. This serves as an incentive for pharmaceutical companies and biotechnology start-ups to involve Hong Kong in their research, development and clinical trials. WHO recognition and full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – which brings together regulatory authorities and the pharmaceutical industry – would flag compliance with global standards. By integrating international best practices with the institutional backing of China’s National Medical Products Administration, Hong Kong would be positioned to act as a regulatory gateway bridging Eastern and Western medicine. The early success of transitional measures, such as a drug approval mechanism currently depending on only one external authority, has already expedited local pathways for new therapies. The CMPR initiative promises a win-win outcome for economic diversification and public health. It offers swifter access to cutting-edge medicine while fostering a biomedical ecosystem that can help spearhead innovation. Setting up a globally recognised drug evaluation operation might be challenging, but it is a necessary strategic socio-economic investment.