The Hong Kong Department of Health successfully held the first introduction seminar on the new drug registration application process under the "1+" mechanism.

The Hong Kong Department of Health held its first "1+" new drug registration application briefing yesterday, introducing the registration requirements for pharmaceutical products under the "1+" mechanism to industry practitioners and stakeholders. They also announced upcoming drug registration workshops and pre-application consultation services for "1+" new drug registration applicants. Starting from the second half of this year, the Department of Health will provide pre-application consultation meetings for those interested in submitting "1+" registration applications to provide specific guidance on planning the new drug application approval process and enhancing the quality of application documents to improve processing efficiency. The Chief Executive's Policy Address for 2024 proposed to provide pre-application consultation services for "1+" new drug registration applicants to enhance the efficiency of processing related applications. These consultation services include briefing sessions, workshops, and pre-application consultation meetings. The briefing session held yesterday was attended by 76 representatives from local or overseas pharmaceutical companies, consultancy firms, and research institutions, who responded enthusiastically, marking the beginning of a series of consultation services. The Department of Health will hold two more briefing sessions on April 21st and May 16th this year, and interested individuals can visit the Department of Health's Drug Office "1+" mechanism web page for more information and registration. The Hong Kong Special Administrative Region implemented the "1+" mechanism on November 1, 2023, to facilitate the registration of new drugs for the treatment of severe or rare diseases in Hong Kong. The Hong Kong government also expanded the "1+" mechanism to include all new drugs from November 1st last year, including products containing new drug ingredients or biological elements, drugs for new indications, vaccines, and advanced therapy products. Under the "1+" mechanism, if a new drug can provide locally relevant clinical data that meets the requirements and is approved by local experts, it only needs to submit a permit from one (instead of the previous two) reference regulatory authority in order to apply for registration in Hong Kong.