The Zhitong Finance App learned that on November 13, the “Drug and Medical Device Supervision and Administration Center Bill” was gazetted to establish the legal status of the Drug and Medical Device Supervision and Administration Center and rationalize the regulatory framework for Chinese and Western medicines and future medical devices. The Bill will be submitted to the Legislative Council for first reading on November 25.
The Secretary for Health and Services of Hong Kong, Professor Lo Chung-mau, said, “The establishment of the Pharmaceutical Devices Supervision Centre is an important milestone in the reform of the pharmaceutical device supervision system in Hong Kong. The Hong Kong Government will comprehensively and proactively connect with the national “15th Five-Year Plan”, give full play to Hong Kong's unique advantages of supporting the motherland and connecting the world under 'one country, two systems', establish a more proactive drug review and approval mechanism, so that advanced pharmaceutical devices can be introduced to Hong Kong more quickly, benefit patients, and promote Hong Kong to become an international medical innovation hub.”
“We will continue to deepen cooperation with global regulators, seek international recognition, and develop the Pharmaceutical Device Regulatory Center into an authoritative international pharmaceutical supervisory authority in the long term.”
The main recommendations of the Bill include: (1) establishing the Medicines Control Centre as a corporate body to represent Hong Kong, China, in international drug control matters and establish formal and long-term working relationships with international high-level regulators; (2) transferring the regulatory powers and functions currently distributed among the Hong Kong Pharmaceuticals and Poisons Board, the Chinese Medicine Unit under the Hong Kong Chinese Medicine Council and its committees after legislation to the Director of Health of Hong Kong to unify the regulatory framework; and (3) improve the relevant supporting mechanisms and requirements Technical revisions.
Professor Lo Chung-mau emphasized, “The Hong Kong Government is committed to creating a world-class and modern regulatory environment. Under the premise of ensuring the safety, quality and efficacy of pharmaceutical devices, the Hong Kong Government will accelerate the clinical application of innovative pharmaceutical devices, achieve 'Good Medicine for Hong Kong, Good Devices for Hong Kong', and support emerging industries in biomedical technology research and development to help 'bring in and go' innovative pharmaceutical devices.”