發佈日期: 2025-06-26 20:14
TVB News
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The Department of Health plans to set up Hong Kong's own regulatory body for medical products by the end of next year.
The city will be able to approve new medicines based on local clinical data without relying on other regulatory authorities.
Currently, pharmaceutical companies have to present registration approval for their new medicines from at least one regulatory body on a list of reference places in order to be eligible to apply for registration in Hong Kong.
The government is planning to establish the city's own centre for medical product regulation by the end of next year at the earliest.
This is part of the initiatives announced by Chief Executive John Lee in his 2023 policy address to develop Hong Kong into an international health and medical innovation hub.
During the first phase in 2026, the primary evaluation mechanism will begin with extended applications for registered chemical entities.
The centre aims to cover all new medicines and medical devices by 2030.
Companies have to provide raw data for medicines, such as local clinical trial data.
Frank Chan, Assistant Director of Health (Drug) said, "for example, there are some eye drops which have already been used to extend pupils for diagnostic use. But we know that this eye drop can be used for slowing the progress of myopia. When they try to add this new indication, they can use their new data to support this already registered product because the safety (issue) is quite guaranteed."
The Department of Health said with the primary evaluation for all medical products in Hong Kong, residents can have more choices on medical products.
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