Hong Kong to Establish Drug and Medical Device Regulatory Authority by End of Next Year

In a significant move towards enhancing Hong Kong's position as a medical innovation hub, the Hong Kong government has announced the establishment of the Hong Kong Drug and Medical Device Regulatory Authority by the end of next year. This development was highlighted in the recent Policy Address, which proposed the creation of a "first-tier approval" process for drug and medical device registrations, allowing direct approval in Hong Kong without relying on international regulatory permissions.

Today, Director of Health Dr. Lam Man Kin confirmed that the new authority would be up and running by the end of next year. It plans to implement the first-tier approval mechanism for new drug registrations in phases beginning next year. The preparatory work encompasses three strategic directions: promoting quality regulation, fostering innovation in pharmaceuticals and medical devices, and deepening cross-regional cooperation.

Hong Kong to Establish Drug and Medical Device Regulatory Authority by End of Next Year

Assistant Director of Health Chan Ling Fung noted that Hong Kong currently achieves first-tier approval for traditional Chinese medicine and medical devices. However, Western pharmaceuticals still require second-tier approval, relying on approvals from international regulatory bodies. The phased implementation aims for full enactment by 2030, adopting a low-risk, high-safety approach.

At the outset in 2026, the focus will be on extending the registration of chemically registered drugs, such as dosage adjustments and new indications. Subsequently, the process will expand to more complex biological drugs and ultimately all new pharmaceuticals. Chan explained that this gradual approach would allow the industry to adjust to the regulatory requirements progressively.

Assistant Director of Health Simon Chan added that the new center's responsibilities will include clinical trial approvals and post-registration modifications, adhering strictly to the guidelines and standards of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

In terms of regulatory advancements, the government is drafting new legislation to empower the center to regulate both Western and Chinese medicines, and establish a statutory regulatory system for medical devices. New laws are expected to be introduced to the Legislative Council next year. Further, the broader regulatory frameworks for Chinese and Western medicines will be enhanced, aligning with the Traditional Chinese Medicine Development Blueprint to be announced later this year.

To bolster its regulatory capabilities, the Department of Health plans to recruit experts to join the center and introduce international best practices. These practices will include the latest ICH standards for clinical trial quality management starting next year. The authorities also aim to strengthen partnerships with stakeholders and international regulatory bodies, particularly in the Greater Bay Area, and they hope to apply for ICH regulatory membership by 2027, seeking global recognition of Hong Kong's regulatory system.

The first-tier approval process will roll out in four stages, initially assessing registered chemical drugs for new applications, followed by biological drugs, non-original drugs, and advanced therapy products. This measured approach aims to allow continuous fine-tuning of the process, providing the industry with the opportunity to become familiar with submission procedures.

Simon Chan emphasized that while Hong Kong currently requires drugs to be registered overseas before local registration, this new process could cut down registration time by up to 18 months. Though specific target processing times are not yet disclosed, he indicated that a "1+ mechanism" aims for a review period of 150 days, making it one of the fastest in similar approvals.

The consolidation of existing departments overseeing the approval of Chinese and Western medicines and medical devices, involving over 400 staff, will form the backbone of the new center. The Department of Health is committed to strengthening training, including overseas courses and expert collaborations, ensuring a range of expertise necessary for the new regulatory framework.

This comprehensive approach signifies Hong Kong's commitment to advancing its drug and medical device regulatory standards, paving the way for its standing in international health and safety benchmarks.