Briefing seminar on the "1+" mechanism for new drugs
"The Chief Executive's 2024 Policy Address" announced that a consultation service for new drug applications (NDAs) under the "1+" mechanism will be introduced to enhance the efficiency of processing relevant applications. The consultation service comprises briefing seminars, workshops and pre-NDA meetings.
The Department of Health held two briefing seminars on the "1+" mechanism for new drugs on 31-03-2025 and 22-04-2025 with an introduction of the requirements for registration of pharmaceutical products under this mechanism, as well as the upcoming workshops on good regulatory practices and pre-NDA meetings. The two seminars were well received and were attended by 129 representatives from pharmaceutical and consultation companies inside or outside Hong Kong, as well as scientific research institutions.
The Drug Office has prepared the following briefing video to facilitate traders to understand the "1+" mechanism.
Online briefing seminars will be held on the following dates. Please click the preferred date for registration. A confirmation email will be sent to successful registrants three days before the briefing seminars.
Briefing Session on Extension of the "1+" Mechanism
The Drug Office explained on the recent updates to the requirements regarding the extension of the "1+" Mechanism for applications for registration of pharmaceutical products containing new chemical or biological entities in the briefing session organized for the Hong Kong Association of the Pharmaceutical Industry (HKAPI). The briefing was followed by a meeting with the HKAPI Regulatory Affairs Working Group on matters related to new drug applications.
A total of 140 participants attended the briefing session.
19-11-2024
21-11-2024
29-11-2024
Briefing Seminar on Extension of the "1+" Mechanism
The Drug Office organized online briefing sessions for the trade on the extension of the "1+" mechanism for applications for registration of pharmaceutical products containing new chemical or biological entities ("NCE products"). The scope of the "1+" mechanism was expanded to all NCE products, including vaccines and advanced therapy products. The extension came into effect on 01-11-2024.
In connection with the extension of the mechanism, the composition of the Expert Group for Drug Registration ("Expert Group") and the Core Team under the Expert Group was also expanded.
A total of 156 participants attended the series of briefing seminars.
15-07-2024
18-07-2024
23-07-2024
Briefing Seminar on Incentive Measures under "1+" Mechanism
The Drug Office organized online briefing sessions for the trade on the incentive measures for applications for registration of pharmaceutical products under "1+" mechanism, including initiating legislative amendment procedures upon receipt of an application for screening and allowing use of electronic product information (collectively referred to as "ePI") as pilot run.
The above said incentive measures for pharmaceutical companies to submit their new drug applications under the "1+" mechanism came into effect on 01-07-2024.
A total of 132 participants attended the series of briefing seminars.
30-04-2024
Briefing Session on "1+" Mechanism and Enhancement Measures
The Drug Office provided an overview of the recent updates to the policy, titled "Enhancement of Evaluation Procedures for Applications for Registration of Pharmaceutical Products under the "1+" Mechanism" in the briefing session co-organized by the HKAPI Regulatory Affairs Working Group and the Department of Pharmacology and Pharmacy of the University of Hong Kong.
A total of 140 participants attended the briefing session.
29-04-2024
03-05-2024
09-05-2024
Briefing Seminar on Enhancement under "1+" Mechanism
The Drug Office organized online briefing sessions for the trade
on the enhancement of evaluation procedures for applications for registration of pharmaceutical products under "1+" mechanism, including the refuse-to-file mechanism, expansion of Expert Group for Drug Registration and Stop-clock mechanism with a target processing time. The above said enhancement measures came into effect on 01-05-2024.
A total of 188 participants attended the series of briefing seminars.
10-04-2024
Briefing to the Wholesale and Retail Task (WRTF) Force on "1+" Mechanism
The Drug Office briefed the WRTF under the Business Facilitation Advisory Committee on the "1+" mechanism for the registration of new drugs in treating life-threatening or severely debilitating diseases in Hong Kong.
The WRTF welcomed the "1+" mechanism, and considered the mechanism would enable Hong Kong to be more proactive in expediting the approval of applications for registration of new drugs for life-threatening or severely debilitating diseases and would also strengthen Hong Kong's capacity of drug evaluation.
13-11-2023
17-11-2023
20-11-2023
23-11-2023
Briefing Seminar on Updates on Registration Requirement of Pharmaceutical Products containing New Chemical or Biological Entities
The Drug office organized online briefing sessions for the trade on the new "1+" mechanism for the registration of pharmaceutical products containing new chemical or biological entities ("NCE products") for life-threatening or severely-debilitating diseases which came into effect on 01-11-2023.
Under the new mechanism of "1+", applications for registration of NCE products that cannot provide the official evidence of registration approval in two or more of the listed reference countries may still be accepted for evaluation on a case-by-case basis.
A total of 175 participants attended the series of briefing seminars.
