Hong Kong health authorities aim to introduce a fast-track approval mechanism for life-saving drugs that can treat severe or rare diseases, a move that could reduce the current system’s processing time by one-third.
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Secretary for Health Lo Chung-mau said on Thursday that the fast-track arrangement could help to respond to health emergencies such as a pandemic where infections spread quickly. The minister was elaborating on health measures outlined in the latest policy address a day earlier.
“The purpose of the fast-track drug approval mechanism is to address critical medical needs,” he said.
“When an outbreak of a novel infectious disease led to the Covid-19 pandemic, all countries adopted a fast-track approval mechanism for new vaccines and drugs … facing the tsunami of a new infectious disease, everyone was looking for the best way to cope.”
In his latest policy blueprint, Chief Executive John Lee Ka-chiu said on Wednesday that the government would expedite a “1+” mechanism for new drugs, piloting priority evaluation and approval for innovative drugs recommended by the Hospital Authority for the treatment of severe or rare diseases.
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The 1+ mechanism is a streamlined approval process that only requires pharmaceutical products that have local clinical data to be certified by one of the 36 reference drug regulatory authorities before applicants can seek local registration.
Before the introduction of the 1+ mechanism, the certification of two reference authorities was needed to make an application for local registration.