Hong Kong will start reviewing and approving drugs independently in phases when the city鈥檚 regulatory agency begins operation as early as the end of next year, health authorities have announced, as more new medications are expected to hit the city鈥檚 market.
The Department of Health on Thursday revealed its plan to set up its drug regulatory authority as part of the city鈥檚 ambition to become an international hub for health and medical innovation.
The Hong Kong Centre for the Medical Products Regulation, aimed to be a leading international regulatory authority, is slated to be established by the end of 2026.
鈥淲ith next year鈥檚 phased implementation of the primary evaluation approach, we hope that there will be more new drugs entering Hong Kong鈥檚 market,鈥 Director of Health Dr Ronald Lam Man-kin said.
Hong Kong first raised its plan to establish an agency to approve drugs on a 鈥減rimary evaluation鈥 approach in Chief Executive John Lee Ka-chiu鈥檚 2023 policy address.
Primary evaluation means approving drugs based on their clinical trial data, without relying on registration approval from other regulatory authorities.
The department said it was expected to implement the primary evaluation gradually over five years.
鈥淲e will start with drugs with lower risks and a higher safety level鈥opefully our approval ability will be strengthened in phases,鈥 Frank Chan Ling-fung, assistant director of health in charge of drugs, said.
The centre will start looking into extended applications of chemical drugs that have already been registered, such as seeking approval to change the dosage or the conditions under which the drugs could be used.
It will then cover applications for different uses of biological drugs that have been registered and certain advanced therapy products at a later stage.
The centre aims to independently approve all new drugs by 2030.
A preparatory office for the centre was set up in June last year to study and plan for a drug regulatory regime.
According to Lam, the department currently has 60 specialists from various fields offering advice on specific drug-vetting procedures. It also has a panel of global experts.