Hong Kong Launches Primary Evaluation System for Independent Drug Approval
核心洞察
Hong Kong's Department of Health has begun phased implementation of "primary evaluation" for new drug registration, starting with extended applications for locally registered chemical entities.
The new system enables independent assessment of preclinical and clinical data without relying on overseas regulatory approvals, building on the successful "1+" mechanism that has approved 19 products since 2023.
Full implementation is planned by 2030 with the establishment of the Hong Kong Centre for Medical Products Regulation (搜索) in 2026, aimed at accelerating patient access to innovative treatments.
Hong Kong's Department of Health has initiated the phased implementation of a comprehensive "primary evaluation" system for new drug registration, marking a significant shift toward regulatory independence in pharmaceutical approval processes. The initial phase, which began on March 31, 2026, covers applications for extended uses of locally registered chemical entities, including new indications, strengths, posology, and dosage forms.
Transition to Independent Assessment
The primary evaluation system represents a fundamental change in Hong Kong's drug approval framework. Under this new mechanism, officials will independently assess primary data from preclinical trials, clinical studies, pharmacovigilance, manufacturing, and quality control processes throughout a drug's lifecycle. This comprehensive approach eliminates the previous dependence on overseas regulatory authorities for approval decisions.
The Department of Health has notified pharmaceutical associations and stakeholders about the new system and plans to conduct online briefing seminars to explain implementation details. The transition builds on the foundation established by the "1+" drug approval mechanism, which was implemented in November 2023.
Building on the "1+" Mechanism Success
The "1+" pathway has demonstrated significant success since its launch, initially covering treatments for life-threatening or severely debilitating diseases before expanding to all new drugs in November 2024. Under this mechanism, companies can seek authorization in Hong Kong after receiving approval from one overseas reference agency, rather than the previously required two approvals.
Since implementation, 19 new drugs have been approved under the "1+" mechanism, with seven already listed in the Hospital Authority (搜索) Drug Formulary. This success has brought new treatment options to patients while attracting increased drug research and development activities to Hong Kong.
Strategic Timeline and Infrastructure Development
The Hong Kong Special Administrative Region Government has established ambitious milestones for regulatory development. The Hong Kong Centre for Medical Products Regulation (搜索) is scheduled to launch in 2026, serving as the dedicated agency for drug and medical device registration under the primary evaluation model.
The government aims to achieve full coverage of all pharmaceutical products by 2030, enabling complete independence in assessing and approving new drug safety and efficacy based on clinical data. This timeline reflects a systematic approach to building regulatory capabilities while maintaining safety standards.
Clinical and Industry Impact
The primary evaluation system is designed to accelerate the introduction of innovative medical products by eliminating waiting periods associated with overseas approvals. This approach is expected to benefit multiple stakeholders, including patients seeking faster access to breakthrough treatments and the broader medical research ecosystem in Hong Kong.
The Office for Introducing Innovative Drugs and Medical Devices (搜索) under the Hospital Authority (搜索) will play a key role in identifying beneficial treatments for local patients. This office will proactively engage with manufacturers and utilize the "1+" mechanism to bring cost-effective innovative drugs and medical devices to Hong Kong.
Regulatory Framework and Quality Assurance
The new evaluation process maintains rigorous standards for safety, efficacy, and quality assessment. Officials will conduct comprehensive reviews of all preclinical and clinical data, ensuring thorough evaluation before market approval. The system also includes post-market surveillance and monitoring capabilities to maintain ongoing safety oversight.
The phased implementation approach allows for systematic development of regulatory capabilities while maintaining current approval pathways. Companies may continue using existing submission processes during the transition period, providing flexibility as the new system becomes fully operational.
The initiative represents Hong Kong's commitment to establishing itself as a regional hub for pharmaceutical innovation while ensuring patient access to safe and effective treatments through independent regulatory assessment.