DH offers consultation services for new '1+' drug applications

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 this month on the 31st.

The authority will also launch drug registration workshops in June and pre-registration consultation meetings from September to December.

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

Assistant Director of Health (Drug) Frank Chan Ling-fung stated on Monday that by mid-month, the “1+” mechanism had received over 400 inquiries from more than 110 pharmaceutical companies, with approximately 15 percent being verbal and 85 percent written.

He noted that many pharmaceutical companies, particularly those from overseas, are unfamiliar with the mechanism and may not be able to visit Hong Kong for inquiries. 

To improve application efficiency, the DH will introduce face-to-face consultation services for new drug registration applications.

Chan stated that the introductory seminars and drug registration workshops will be free, while fees for pre-registration consultation meetings will be considered 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. Therefore, we will offer them as complimentary services,” he said.

“But why are we considering recovering costs for the consultation meetings? 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, among other things. All of this involves our colleagues’ approval work, which requires time and resources,” he explained.

The “1+” mechanism was implemented in November 2023 and expanded to include all new drugs as of November last year. 

Under this mechanism, 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.

The DH said that the seminars aim to inform stakeholders about drug registration requirements in Hong Kong and the “1+” mechanism.

The workshops are more practical, targeting regulatory affairs personnel in pharmaceutical companies, those assisting with registration submissions, and staff from registration consultancy firms.

The authority added that pre-registration consultation meetings are designed for pharmaceutical companies capable of producing drugs and/or are seeking or have marketed in any of the reference countries.

(Cheng Wong)