Hong Kong Introduces Fast-Track Drug Approval System to Reduce Review Time by 33%
Key Insights
Hong Kong health authorities are implementing an enhanced fast-track approval mechanism that will reduce drug review time from 150 days to 100 days for priority medications treating severe or rare diseases (search).
The enhanced "1+" mechanism builds on the existing system launched in November 2023, which has already approved 14 new drugs covering cancer (search), hematological conditions (search), and chronic kidney disease (search) treatments.
Seven of the approved drugs have been included in the Hospital Authority (search)'s Drug Formulary, demonstrating the system's effectiveness in expediting access to critical medicines.
Hong Kong health authorities are set to implement an enhanced fast-track drug approval system that will reduce review times by one-third, cutting the standard 150-day approval period to just 100 days for priority medications. The initiative, announced by Chief Executive John Lee Ka-chiu in the latest Policy Address, targets innovative drugs for treating severe or rare diseases (search) and addressing critical public health needs.
Enhanced "1+" Mechanism Shows Early Success
The existing "1+" mechanism, which launched in November 2023, has already demonstrated significant effectiveness in streamlining drug approvals. Since its implementation, 14 new drugs have been approved through this system, covering treatments for cancer (search), hematological conditions (search), and chronic kidney disease (search). According to Secretary for Health Lo Chung-mau, seven of these approved medications have been successfully incorporated into the Hospital Authority (search)'s Drug Formulary.
The current "1+" mechanism represents a substantial improvement over previous requirements, allowing pharmaceutical companies to seek local registration with certification from just one of the 36 reference drug regulatory authorities, compared to the previous requirement of two certifications. This streamlined process requires local clinical data and expert endorsement on the drug's suitability for the Hong Kong market.
Addressing Critical Medical Needs
"The purpose of the fast-track drug approval mechanism is to address critical medical needs," Lo explained during a Thursday news conference. He emphasized the system's importance during health emergencies, referencing the COVID-19 (search) pandemic as an example where rapid drug and vaccine approvals became essential globally.
Director of Health Ronald Lam Man-kin described the "1+" mechanism as "a vital enhancement to the drug regulatory system," noting that the next phase will focus on providing expedited pathways for innovative drugs treating major diseases, rare disorders, and those addressing significant public health crises.
Coordinated Approach with Hospital Authority
The enhanced system will operate in close coordination with the Hospital Authority (search) to prioritize drugs deemed critically important for the public healthcare system. "In coordination with the Hospital Authority, we will prioritize the review of drugs deemed critically important for the public healthcare system," Lam stated.
While Hong Kong's current 150-day standard already ranks among the most efficient globally, the government's target of reducing this to 100 days for priority cases represents a significant advancement in regulatory efficiency. The Health Bureau (search) has committed to monitoring the performance of the new fast-track initiative and making adjustments after an initial implementation period, while ensuring drug safety remains paramount.
Broader Healthcare System Strengthening
Lo emphasized that the fast-track approval mechanism is part of a broader strategy to strengthen Hong Kong's healthcare infrastructure. "Health is both a foundation of people's livelihoods and a cornerstone of the economy," he noted, outlining the government's commitment to enhancing the public healthcare system's safety, quality, and efficiency while optimizing departmental service processes to make healthcare services more compassionate.