Hong Kong Launches Primary Evaluation Phase 1 for NDAs

On March 31, 2026, the Hong Kong Pharmacy and Poisons Board introduced Phase 1 of the Primary Evaluation pathway for New Drug Applications (NDAs) and revised the “Guidance Notes on New Drug Applications,” effective immediately — formally expanding the regulatory framework to three evaluation routes.

For regulatory and development teams, this change goes beyond a procedural update — it reshapes how NDA strategies must be structured from the earliest planning stages in Hong Kong.

At a Glance

• Hong Kong now has three evaluation pathways for new drug applications: Primary Evaluation, Abridged Evaluation, and Verification
• Primary Evaluation Phase 1 is limited in scope and does not apply to most first‑time NDAs
• The Abridged Evaluation (“1+” mechanism) remains the main pathway for innovative drugs already approved in mainland China or other reference jurisdictions
• Pathway selection is mandatory and based on objective eligibility criteria
• Early regulatory strategy and engagement are increasingly critical

Evolving Regulatory Framework in Hong Kong

To understand the significance of this update, it is important to consider how Hong Kong’s regulatory system has been evolving.

Historically, Hong Kong has relied on approvals from recognized overseas regulatory authorities to support local drug registration. This reliance-based system was partially reformed in November 2023 with the introduction of the “1+” mechanism, which allows certain new drugs to be registered based on approval from a single reference jurisdiction, supported by local or Asian clinical data.

The reforms announced on March 31, 2026 build on this foundation and represent the next phase in Hong Kong’s long-term policy objective to establish independent regulatory evaluation capabilities. These efforts align with broader plans to develop the Hong Kong Centre for Medical Products Regulation (CMPR) and achieve full primary evaluation capacity by 2030.

Applicants submitting NDAs in Hong Kong are now required to select one of three evaluation routes, rather than two as previously:

1. Primary Evaluation
2. Abridged Evaluation
3. Verification

This shift formalizes pathway selection as a mandatory step and places greater emphasis on upfront regulatory strategy, rather than post-submission positioning.

The Three Evaluation Pathways Explained

With three distinct routes now in place, understanding their respective roles — and limitations — is essential for effective submission planning.

Primary Evaluation Pathway

The Primary Evaluation pathway introduces independent review capability, but its application remains deliberately limited in Phase 1.

• Applies where the product has not been approved in any recognised reference jurisdiction
• In Phase 1, eligibility is limited to extended applications (e.g. new indications, strengths, dosage forms) for already registered chemical entities
• Involves independent assessment of full primary data, without reliance on overseas approvals
• Requires a mandatory Pre-NDA meeting with the Drug Office prior to submission

Abridged Evaluation Pathway (Including the “1+” Mechanism)

By contrast, the Abridged Evaluation pathway continues to serve as the primary route for most innovative drugs seeking first-time registration in Hong Kong.

This pathway applies where defined reliance criteria are met and includes the “1+” mechanism. Under this mechanism, a product must:

• Be approved in at least one recognized reference jurisdiction
• Hold orphan drug, breakthrough therapy, priority review, or equivalent designation
• Be supported by local or Asian clinical data

In practice, this remains the most relevant pathway for innovative products already approved in mainland China or other key markets.

Verification Pathway

At the other end of the spectrum, the Verification pathway is designed for products with extensive prior approvals.

• Applies to products approved in two or more recognized reference jurisdictions
• Involves the highest level of reliance and typically the least independent reassessment

Implementation Timeline and Regulatory Roadmap

To support planning, the rollout of this framework follows a clearly defined timeline:

• 31 March 2026 – Phase 1 of Primary Evaluation officially launched
• From 31 March 2026 onward – All NDAs must select one of the three evaluation routes at submission
• 2026–2030 – Phased expansion of Primary Evaluation as Hong Kong builds independent regulatory capacity

Implications for Industry and Regulatory Strategy

Taken together, these changes introduce new considerations for sponsors preparing NDA submissions in Hong Kong.

• Sponsors must objectively assess eligibility before submission, as misclassification may lead to refuse‑to‑file outcomes.
• Phase 1 has a limited scope and does not replace reliance‑based pathways for most new chemical or biological entities.
• For innovative drugs already approved in mainland China or other reference jurisdictions, Abridged Evaluation under “1+” continues to be the most relevant route.
• Pre‑NDA meetings and early data strategy alignment are key to managing regulatory risk.

Final Thoughts

The launch of Phase 1 of the Primary Evaluation pathway is a meaningful milestone in Hong Kong’s regulatory evolution, but it does not fundamentally displace existing reliance‑based routes at this stage. Instead, it reinforces the need for clear pathway selection, realistic expectations, and early regulatory strategy.

For companies pursuing new drug registration in Hong Kong, the opportunity lies in getting the pathway decision right from the outset — and avoiding delays caused by eligibility or screening issues. Cisema supports clients by navigating pathway selection, shaping regulatory strategy, and engaging effectively with Hong Kong authorities to ensure submissions are aligned with the latest regulatory framework.

Contact Cisema today to discuss your Hong Kong drug registration strategy.

Further Information

Explore Cisema’s services for Hong Kong Drug Registration.

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

• Hong Kong Department of Health press release on Primary Evaluation, March 31, 2026
• Pharmacy and Poisons Board of Hong Kong – Revised Guidance Notes for NDAs

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