Hong Kong Launches One-on-One Pre-Application Meetings to Accelerate Drug Approvals Under "1+" Mechanism
核心洞察
Hong Kong's Department of Health has introduced one-on-one pre-new drug application meetings for companies seeking registration under the "1+" mechanism, effective immediately and offered free of charge.
The new consultation service includes company-oriented meetings for first-time applicants and product-specific sessions to provide tailored regulatory guidance and streamline submission processes.
Since implementation in November 2023, the "1+" mechanism has approved 16 new drugs with seven listed in the Hospital Authority (搜索) Drug Formulary, while receiving over 700 inquiries from 180+ pharmaceutical companies.
Hong Kong's Department of Health (DH) has launched one-on-one pre-new drug application (pre-NDA) meetings for pharmaceutical companies seeking to register innovative therapies under the territory's "1+" mechanism, effective December 22, 2025. The new consultation service aims to streamline drug approval processes and reinforce Hong Kong's position as an international health and medical innovation hub.
Enhanced Consultation Framework
The pre-NDA meetings represent the latest addition to a comprehensive support framework for companies utilizing the "1+" pathway, which comprises three elements: briefing seminars, technical workshops, and the newly introduced one-on-one meetings. According to the DH, these sessions are designed to provide tailored regulatory guidance at early stages, reduce procedural uncertainty, and improve submission quality.
Two distinct meeting formats are available to address different industry needs. Company-oriented meetings target firms applying through the "1+" mechanism for the first time, where DH specialists provide advice on appropriate drug registration categories and suitable application routes based on the company's profile and product pipeline. Product-specific meetings focus on individual new drug projects, with DH professionals outlining evidentiary expectations, procedural steps, and documentation requirements for particular applications.
Strong Industry Engagement
Since March 2025, the DH has conducted seven briefing seminars explaining basic requirements and procedural frameworks for new drug registration under the "1+" mechanism. Additionally, three workshops have provided detailed guidance, shared best practices, and presented real-world case experiences. These outreach activities have attracted more than 580 participants from pharmaceutical companies, consultancy houses, and research institutions both within and outside Hong Kong.
To encourage industry adoption, the DH has indicated that no fees will be levied for the pre-NDA meeting service at this stage. The department has committed to maintaining close dialogue with industry stakeholders and collecting feedback to refine the meeting format and effectiveness over time.
"1+" Mechanism Performance
The Hong Kong Special Administrative Region (搜索) implemented the "1+" mechanism on November 1, 2023, extending it to all new drugs from November 1, 2024. This includes new chemical or biological entities, new indications, vaccines, and advanced therapy products. Under this framework, new drugs supported by local clinical data and recognized by local experts can be registered by submitting approval from one reference regulatory authority, rather than the previous requirement of two.
Since implementation, 16 new drugs have been approved under the "1+" mechanism, with seven listed in the Hospital Authority (搜索) Drug Formulary. The DH has received more than 700 inquiries from over 180 pharmaceutical companies, including those from the Chinese Mainland and overseas markets.
Future Regulatory Reforms
The Chief Executive's 2025 Policy Address announced accelerated reform of Hong Kong's regulatory system for drugs and medical devices. The DH plans to pilot priority evaluation and approval of innovative drugs recommended by the Hospital Authority (搜索) for treating severe or rare diseases, expediting patient access to advanced treatments.
By the end of 2026, Hong Kong will establish the Hong Kong Centre for Medical Products Regulation (搜索) and implement "primary evaluation" for new drug registration in phases beginning in 2026. These initiatives are designed to provide momentum for healthcare industry development and market expansion across Hong Kong, the Chinese Mainland, and international markets.