Hong Kong 1+ Mechanism: Accelerating Access through New Drug Applications

The Hong Kong 1+ pathway for new drug applications (NDAs) allows submissions based on prior approval from one trusted regulatory authority (“1”) along with additional data applicable to the Hong Kong population (“+”). This pathway came into effect on November 1, 2023, offering an alternative route for NDAs that require documentary proof of registration approval from drug regulatory authorities in two or more reference countries.

Since implementation, several new chemical entity (NCE) products have been successfully registered under this mechanism, including targeted therapies, novel biologics, and treatments for both rare and chronic conditions.

On June 16, 2025, Cisema attended a workshop that provided detailed guidance on this mechanism. Hosted by the Drug Office of the Hong Kong Department of Health, the “Workshop for New Drug Applications under the ‘1+’ Mechanism” was designed to assist applicants considering this pathway.

Examples of Products Already Approved Under the Hong Kong 1+ Mechanism

SpecialtyProduct Name & Active IngredientIndicationsOncologyElunate Capsules (Fruquintinib)Metastatic colorectal cancerOncologyImdelltra Powder for Concentrate and Solution for Infusion (Tarlatamab)Small cell lung cancerOncologyOrpathys Tablets (Savolitinib)NSCLC with MET exon 14 skipping alterationsNephrologyFabhalta Capsules (Iptacopan)Paroxysmal nocturnal hemoglobinuriaNephrologyEvrenzo Capsules (Roxadustat)Anemia in chronic kidney diseaseNephrologyOrkedia Tablets (Evocalcet)Parathyroid disorders

These approvals highlight the practical benefits of the Hong Kong 1+ mechanism and underscore the authority's commitment to expediting patient access to novel treatments while maintaining high regulatory standards. It facilitates faster access to breakthrough drugs, encourages early market entry for globally launched therapies, and reflects a more pragmatic, case-sensitive regulatory posture.

Comparison of Current Registration Pathways:

Below is an example of the existing registration route compared to the “1+” approach:

PathwayKey RequirementsTypical TimelineStandard NDA RegistrationAt least two reference agency approvals, full technical dossier, GMP/GCP compliance12–24 monthsExpedited Registration (“1+”)One reference agency approval plus local clinical/real-world evidence, full technical dossier, GMP/GCP compliance~9–12 months

This comparison illustrates how the “1+” mechanism reduces the burden of evidence required from multiple jurisdictions and shortens the time to market.

Hong Kong’s reforms signal an ambition to position the city as a competitive hub for innovative drug approvals across Asia.

Key Takeaways from the “1+” Workshop

Key takeaways from the Hong Kong 1+ workshop included:

• Pre-submission Meetings: Companies should request one-on-one meetings with the Drug Office in Q3 or Q4 to discuss draft dossiers and receive feedback early in the process.
• Local Expert Requirements: A Hong Kong–based medical specialist with at least five years of relevant experience must write the Local Expert Report. The report should explain how the clinical data supports the drug’s use in Hong Kong, with attention to ethnic relevance.
• Clinical Data Scope: The Drug Office accepts data from Hong Kong, other Asian countries, or ethnic Chinese populations. While local clinical studies are not mandatory, they are highly recommended.
• GMP Certification Process: GMP inspections can begin in parallel with application reviews. Valid GMP certificates from ICH reference authorities (e.g., US FDA, EMA) are generally accepted and may reduce inspection needs.
• Documentation and Language: English is preferred for technical documents. Non-English materials must include certified translations.
• Assessment Reports: Applicants must provide complete and minimally redacted assessment reports from reference authorities. Supplementary reports from other countries can support the submission.
• Review Timelines and Milestones
  • Target review period: 150 working days
  • Response window for applicant: 120 calendar days
  • Initial screening usually completes within 5 months
• Risk Management Plans (RMPs): RMPs are mandatory regardless of whether the reference country requires them. Plans should address post-marketing surveillance, risk minimization strategies, and long-term monitoring—especially for advanced therapies.
• Pathway Selection: The “1+” mechanism complements, but does not replace, the traditional registration route. Applicants should use this route when it provides a regulatory or clinical benefit.
• Expanded Eligibility: The mechanism now applies to breakthrough therapies, some OTC drugs, and treatments relevant to regional public health, beyond life-threatening diseases.

This flexibility makes the “1+” route an efficient option for overseas manufacturers seeking faster entry into Hong Kong.

Further Information

For additional details about the Hong Kong 1+ mechanism, please visit the Drug Office's page.

The establishment of the CMPR and the rollout of primary evaluation has been officially announced by the Department of Health (DH) via email on June 26, 2025. This development represents a major regulatory reform in the approval processes for pharmaceuticals and medical devices in Hong Kong. At the same time, a gradual rollout of a “primary evaluation” system for product approvals will take place, aiming for complete adoption by 2030. For details, please read our dedicated article here.

Learn more about our Hong Kong drug registration services to ensure your products comply with Hong Kong's regulatory requirements.

About the Author: Jacky Li

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