Hong Kong Launches Pre-NDA Meetings Under the “1+” Drug Registration Mechanism

The Department of Health (DH) announced the operational launch of Pre-New Drug Application (Pre-NDA) meetings on December 22, 2025. This initiative provides a formal channel for applicants to request technical consultations, aiming to enhance the efficiency and predictability of new chemical entity (NCE) registrations under Hong Kong’s “1+” mechanism.

The launch delivers on commitments set out in The Hong Kong Chief Executive’s 2024 Policy Address (16 October 2024), which outlined a comprehensive consultation framework for NDAs under the “1+” mechanism. This framework includes briefing seminars, industry workshops, and now applicant-specific Pre-NDA meetings, aimed at strengthening application quality and processing efficiency.

Companies pursuing NCE registration are advised to engage early through these meetings to align with DH expectations and optimize their regulatory timelines.

Strategic Enhancements to the “1+” Registration Framework

Effective immediately from 22 December 2025, prospective “1+” applicants may request applicant-specific Pre-NDA meetings with the Drug Office. This formalises the consultation services previewed in the 2024 Policy Address and complements the DH briefing seminars and workshops conducted throughout 2025.

Key enhancements include:

• Official launch of Pre-NDA meetings: Available to all “1+” applicants from 22 December 2025
• Dual consultation formats: Company-level meetings for first-time applicants and product-specific meetings for individual NDA programs
• Improved regulatory predictability: Early engagement is intended to enhance dossier quality and reduce review cycles
• Cost-effective access: No fees are currently charged for Pre-NDA meetings, lowering barriers to early regulatory alignment
• Alignment with broader reforms: Supports upcoming “1+” enhancements, including the phased introduction of primary evaluation from 2026

Implementation Timeline for New Consultation Services

The introduction of one-on-one Pre-NDA meetings reflects a multi-year reform of Hong Kong’s pharmaceutical regulatory framework. The timeline below illustrates the progression of the “1+” mechanism:

• November 1, 2023: Initial implementation of the “1+” mechanism for NCEs.
• November 1, 2024: Scope expanded to include all new drugs, including vaccines and advanced therapy products (ATPs).
• March–December 2025: DH conducts series of briefing seminars and industry workshops.
• December 22, 2025: Official launch of one-on-one Pre-NDA meetings.
• From 2026: Anticipated commencement of the phased “primary evaluation” drug review process.

What Is Hong Kong’s “1+” Drug Regulatory Mechanism?

Hong Kong’s “1+” mechanism was first implemented on November 1, 2023, and subsequently expanded on November 1, 2024. It allows for the submission of an NDA based on approval from a single recognized reference authority, provided it is supported by local clinical data and recognition by local experts. This streamlined pathway significantly reduces the historical reliance on obtaining approvals from multiple foreign regulatory bodies before entering the Hong Kong market.

Since its introduction, the DH has approved a broad range of innovative therapies under the “1+” mechanism, including small molecules, biologics, antibody-drug conjugates (ADCs), and cell therapies.

Notable approvals under the “1+” framework include:

• ELUNATE (fruquintinib)
• FABHALTA (iptacopan)
• EVRENZO (roxadustat)
• ORPATHYS (savolitinib)
• IMDELLTRA (tarlatamab)
• TEPEZZA (teprotumumab)
• TIVDAK (tisotumab vedotin)
• HYMPAVZI (marstacimab)
• FUCASO (equecabtagene autoleucel)

The success of these registrations underscores the mechanism's versatility across therapeutic areas such as oncology, nephrology immunology, and rare diseases. For more details, please refer to the List of Pharmaceutical Products Registered Under "1+" Mechanism.

Opportunities for International Pharmaceutical Manufacturers

The formal introduction of Pre-NDA consultations under Hong Kong’s “1+” mechanism offers international sponsors a chance to engage early, clarify expectations, and optimise their regulatory strategy. This early engagement is particularly valuable for complex therapeutic programs, where aligning with the Drug Office upfront can save time and resources.

Key opportunities include:

• Potential to reduce downstream risk: Clarifying evidence requirements early could help minimise queries and review cycles.
• Validating regulatory strategy for new entrants: New entrants to the “1+” mechanism can validate their overall regulatory approach before committing resources.
• Receiving tailored feedback for complex programs: Product-specific discussions may provide focused feedback for advanced therapies, new indications, or expedited pathways.
• Supporting broader regional planning: Early engagement under “1+” can help align strategies across Hong Kong, the Greater Bay Area, and the wider Asia-Pacific market.

Under this mechanism, adopting an early regulatory strategy is increasingly important. Sponsors should assess eligibility, reference markets, and data packages at an earlier stage of development. Taken together, these opportunities help international sponsors align their development programs more effectively and explore ways to accelerate time to market under the “1+” mechanism.

Final Thoughts: Maximising the Value of Pre-NDA Engagement

The Pre‑NDA meeting launch strengthens Hong Kong’s transition to earlier, more predictable, and collaborative drug regulation. As the “1+” mechanism continues to mature and primary evaluation is phased in from 2026, sponsors that engage early — and prepare strategically for Pre-NDA interactions — will be best positioned to accelerate time to market and reduce regulatory uncertainty.

However, realising the full value of Pre-NDA engagement requires a well-defined regulatory strategy and thorough preparation. Cisema supports sponsors across eligibility assessment, Pre-NDA preparation, meeting strategy, and end-to-end “1+” submissions to maximise regulatory clarity and approval efficiency.

Contact Cisema today to explore how our advisory services can support your drug registration strategy in Hong Kong and across Asia Pacific.

Further Information

• Explore our Hong Kong Drug Registration & “1+” Mechanism Advisory Services

About the Author: Jacky Li

Jacky Li is a Senior Manager at Cisema, based in Hong Kong and Taiwan. He has over a decade of experience in regulatory intelligence and market access, and serves as the lead supporting clients across Hong Kong, Mainland China (including the Greater Bay Area), and Taiwan, with a strong focus on pharmaceutical and medical device regulatory projects.

References

• “1+” mechanism for Registration of Pharmaceutical Products containing New Chemical or Biological Entities, last revised on December 22, 2025
• Hong Kong Department of Health – Press Release on One‑on‑One Pre‑New Drug Application Meetings under the “1+” Mechanism, released on December 22, 2025
• The Hong Kong Chief Executive’s 2024 Policy Address, delivered on October 16, 2024