Officials on Thursday also said Hong Kong would start reviewing and approving new drugs independently in phases from 2026, with the aim of implementing “primary evaluation” gradually over five years thanks to the establishment of the Hong Kong Centre for Medical Products Regulation.
Before a pharmaceutical product can be used in Hong Kong, it is required to be registered in at least two of 36 countries specified by officials as part of a process known as a “secondary evaluation” approach.
A new drug can also be registered in the SAR under a separate streamlined mechanism called “1+”, which process requires the approval of just one reference regulatory authority, along with clinical information.
However, Hong Kong may soon adopt the “primary evaluation” approach, meaning it can give drugs the green light based on clinical trial data without relying on approval from other regulatory authorities.
Director of Health Ronald Lam underscored the importance of having drug approval expertise in the city, noting that there are currently 60 professionals assisting with the vetting process.
“With the [centre] coming into being, including internal staff recruitment and also appointment of external experts, we see there is such a need,” Lam said.
“We are not ruling out the possibility of global recruitment.”
Primary evaluation will begin in phases from next year, starting with the extended applications of registered chemical drugs, officials added, but they could not give an estimate on the time required for a new drug to be approved under the local review system.
Frank Chan, an assistant director of health, said pharmaceutical companies have to conduct a number of studies to substantiate a drug’s safety first before they can get to the stage of clinical trials.
“Throughout the phases, we can identify how much time we need to do this kind of evaluation and how much expertise is involved, so that we can set the performance target,” he said.
Officials aim to introduce new laws for medical products from this year and amend existing ordinances after the regulatory centre is set up.
The city currently has observer status at an international council of drug regulators, and officials hope the SAR can apply to become an official member in 2027.
Asked if the new regime will include national security clauses, Lam said the authorities must ensure they would not rely on certain regions for medical products amid the current geopolitical situation.
