Under the mechanism, new drugs that are supported by local clinical data as well as recognised by local experts can apply to get registered in the city by submitting the approval from just one external drug regulatory authority, instead of two in the past.
The newly registered drug has been approved by an authority in the US, and the Registration Committee under the Pharmacy and Poisons Board of Hong Kong considers it to have satisfied safety, efficacy and quality criteria.
“Chronic spontaneous urticaria is a chronic skin condition that causes unpredictable itch and hives, which can profoundly affect the quality of life,” a spokesman said.
“This new drug can provide sustained improvement in symptoms control.”
A total of 22 new drugs have been given the green light for registration since the mechanism was launched in 2023.
The Department of Health has so far received more than 910 enquiries from over 220 pharmaceutical companies over the mechanism, the spokesman said, adding many of them are interested in getting their products registered in Hong Kong.
