Hong Kong to Streamline Approval of Innovative Drugs and Medical Devices

Hong Kong’s Hospital Authority has launched a new office dedicated to fast-tracking the introduction of innovative drugs and medical devices into the public health system. The Office for the Introduction of Innovative Drugs and Medical Devices began operations on June 8, with a mandate to streamline how cutting-edge treatments reach patients in public hospitals.

A key focus of the new office is accelerating drug registration in Hong Kong. Under the existing system, new drugs can take up to 150 working days to clear the Department of Health’s approval process. The office aims to cut that to around 100 working days by working through a dedicated “priority review pathway” — a reduction of roughly one-third. Cancer treatments are expected to be the first category of drugs to benefit from the faster timeline.

The Hong Kong office will not just wait for pharmaceutical companies to come to them. It plans to proactively reach out to drug makers in foreign markets, identifying promising treatments and pushing them through the review process. A committee of specialists, including clinical experts, health economists, and pharmacologists, will assess whether a drug meets unmet local needs and offers value for patients before it gets added to the Authority’s drug register.

Beyond pharmaceuticals, the office will also work to bring innovative medical devices into public hospitals more quickly, connecting manufacturers with the right channels to pursue a Hong Kong listing. The Hospital Authority said it expects the new setup to meaningfully improve patient access to better treatment options, particularly for those with cancer.


Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.