The Health Bureau announced an ambitious target to reduce its new-drug approval time by 33 percent to just 100 days for priority cutting-edge medications under an enhanced “1+” mechanism, from the current 150-day review period for standard applications.

The initiative, highlighted in the latest Policy Address delivered by Chief Executive John Lee Ka-chiu on Wednesday, is designed to expedite the availability of critical medicines for patients with the most urgent needs.

The existing “1+” mechanism, which came into effect in November 2023, already streamlined the registration process for new drugs. It allows for applications based on the approval from one reference drug regulatory authority, instead of two under the previous arrangement, alongside support from local clinical data and expert endorsement on the drug’s suitability.

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Since its launch, the mechanism has proved effective, with 14 new drugs — covering treatments for cancer, hematological conditions, and chronic kidney disease —already approved. Secretary for Health Lo Chung-mau said at the news conference on Thursday afternoon that seven of these drugs have been included in the Hospital Authority’s Drug Formulary.

Director of Health Ronald Lam Man-kin described the “1+”mechanism as “a vital enhancement to the drug regulatory system”, while the next step is to provide a fast channel for innovative drugs that treat major diseases, rare disorders, and those that address significant public health crises.

“In coordination with the Hospital Authority, we will prioritize the review of drugs deemed critically important for the public healthcare system,” Lam said.

While Hong Kong’s current 150-day standard is already among the most efficient globally, the government aims to accelerate the process to 100 days for priority cases. The performance of the new fast-track initiative will be monitored and adjusted after an initial implementation period, and drug safety will be ensured, Lo said.

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Lo also said that health is both a foundation of people’s livelihoods and a cornerstone of the economy, and therefore, the government will continue to strengthen the public healthcare system, enhance the safety, quality, and efficiency of the Hospital Authority’s services, while also optimizing departmental service processes to make healthcare services more compassionate.

Contact the writer at stacyshi@chinadailyhk.com