Hong Kong: "1+" Mechanism Guidance for Faster Approvals

Since 1 November 2023, Hong Kong has embraced the “1+ mechanism”, a progressive pathway for registering new drugs. Under this system, applicants can seek registration with just one approval from a recognized reference regulatory authority, paired with local clinical data and expert validation, rather than the two approvals required in the previous system. In November 2024, the mechanism expanded to cover all new chemical and biological entities, including vaccines and advanced therapies.

This new model blends international trust with local relevance, ensuring safety and efficacy while speeding up patient access to innovative therapies.

To help the industry navigate this regulatory pathway, the Department of Health introduced a structured consultation service, including briefing seminars, workshops, and pre-NDA consultation meetings throughout 2025.

Key Takeaways from the Workshop

Among the highlighted critical practical advice from the Drug Office are:

• Companies are encouraged to engage in one-to-one pre-NDA meetings (expected to be held in Q3 or Q4 2025) to review draft dossiers and secure early feedback.

• Applicants must include a report from a Hong Kong-based medical specialist with a minimum or more than 5 years of relevant experience. The report must clearly explain how clinical data supports use in Hong Kong, emphasizing the ethnic relevance.

• Acceptable data sources for clinical data expectations include Hong Kong, other Asia countries, or ethnic Chinese populations. Local clinical trials are not mandatory but highly recommended.

• GMP inspections can run in parallel with reviews, and recognized GMP certificates are generally accepted, potentially reducing onsite inspection needs.

• Technical documents should preferably be in English or include a certified translation.

• Risk Management Plans (RMPs) are required for all applications, which must address post-marketing surveillance, risk minimization, and long-term monitoring, especially for advanced therapies.

• The “1+” mechanism is complementary, not a replacement for traditional registration routes. Applicants should use it when it offers clear regulatory or clinical advantages.

• Review framework:

  • Target review duration: 150 working days

  • Applicant response window: 120 calendar days

  Initial screening is expected to conclude within five months

  
  

By April 2025, the Department of Health received around 460 enquiries from more than 100 companies that are interested in applying the “1+” mechanism. Since launch, 5 out of 11 new drugs that have been approved via the new mechanism have been listed on the Hospital Authority drug formulary. This response signals strong engagement from the industry.

Developments Benefits for Stakeholders

• Regulatory Applicants may access streamlined approval, expert guidance, and strategic dossier refinement.

• Drug Office and Hong Kong’s Healthcare Ecosystem can enhance industry collaboration and regulatory modernization. While at the same time bridging stronger global positioning as a life sciences hub with efficient regulatory processes.

• Patients and the community can gain quicker access to novel therapies, financial savings, and improved treatment options.

By aligning clarity, efficiency, and international standards, the “1+ mechanism” exemplifies purposeful regulatory innovation. Through consultation services, detailed guidance, and a clear timeline, Hong Kong is paving the way for timely patient access to essential medicines while strengthening its drug evaluation capabilities.

Source: Drug Office