Health department rolls out '1+' seminars

Cheng Wong

The Department of Health will provide consultation services for new drug applications under the "1+" mechanism to enhance processing efficiency, with the first introductory seminar scheduled for March 31st.

It will also launch drug registration workshops in June and preregistration meetings from September to December.

This came as the Hospital Authority revealed that five new medications were registered in Hong Kong under the mechanism, leading to a 30 to 35 percent decline in their prices - saving HK$15 million to HK$24 million annually.

Assistant Director of Health (Drug) Frank Chan Ling-fung said that by mid-March, "1+" had received over 400 inquiries from more than 110 pharmaceutical companies, noting that many of these firms are unfamiliar with the mechanism, particularly those from overseas.

Chan said the introductory seminars and drug registration workshops will be free, while preregistration consultation meetings may have fees to recover costs.

"Introductory seminars and workshops will likely be free of charge, as they are primarily intended to help them understand the basic registration requirements," Chan said, adding that consultation meetings may be paid "because those companies will first submit a pile of documents for our preliminary review, to see what products they are working on, what permits they have obtained and whether they have clinical data this involves our colleagues' approval work, which requires time and resources."

Under "1+" - implemented in November 2023 and expanded to all new drugs a year later - new drugs for life-threatening or severely debilitating diseases can be registered in Hong Kong with approval from just one reference drug regulatory authority, as long as they have recognized local clinical data and expert endorsement.