Hong Kong SAR and NMPA Renew Agreements to Boost Drug and Medical Device Regulation

Professor Chung-mau LO, BBS, JP, Secretary for Health of the Hong Kong Special Administrative Region (SAR) government, held a meeting with Li Li, Director of the National Medical Products Administration (NMPA). The meeting focused on enhancing collaboration regarding drug and medical device approval processes, clinical trials, and the advancement of traditional Chinese medicine (TCM) between mainland China and Hong Kong.

Following the meeting, both parties renewed the Cooperation Agreement on Drug Regulation and the Cooperation Agreement on the Construction, Research, and Management of Chinese Herbarium. This renewal signifies a continued commitment to align regulatory frameworks and foster joint development in these areas.

The Hong Kong SAR government, which was officially recognized as an observer for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), initiated a new drug approval mechanism in October and November 2023. This move aligns with the region’s strategic goal of enhancing its pharmaceutical regulatory environment.

In the first half of 2024, the Hong Kong SAR government plans to establish a drug and medical device supervision and administration center preparatory office. This office will spearhead research aimed at restructuring and bolstering drug and technical supervision and approval systems.

Furthermore, by the end of 2024, the SAR government is set to establish the Greater Bay Area International Clinical Trial Institute in Hetao. This initiative is designed to enhance the capacity and efficiency of clinical trials in Hong Kong, with the ambition of positioning Hong Kong as a leading clinical trial hub in the Asian region.- Flcube.com

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