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 eight briefing seminars on the "1+" mechanism for new drugs from March 2025 to March 2026 with an introduction of the requirements for registration of pharmaceutical products under this mechanism, as well as the workshops on good regulatory practices and pre-NDA meetings. The eight seminars were well received and were attended by 260 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.
Please refer to the latest “Guidance Notes on Registration of Pharmaceutical Products: New Drug Applications”
for the procedures and requirements for applications for initial registration of pharmaceutical products containing new chemical or biological entities, Advanced Therapy Products, and related applications, collectively referred to as new drug applications. NDAs for initial registration can be submitted via “1+” mechanism under Abridged evaluation.
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.
Workshop for New Drug Applications under "1+" Mechanism
"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 organized four Workshops for New Drug Applications under "1+" Mechanism from June 2025 to April 2026. The workshop for provision of guidance and sharing of good practices and real-life experiences on submitting applications through the "1+" mechanism was significantly effective, attracted keen participation by over 390 representatives, primarily from the regulatory affairs departments of pharmaceutical and consultancy companies in Hong Kong. With the active participation from the industry, it is envisaged that the quality and efficiency for new applications submitted under "1+" mechanism will further be enhanced.
Details of a re-run of the workshop will be announced in due course.
"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 has launched the Pre-NDA Meetings with effect on 22 December 2025. The Pre-NDA Meetings aim to enhance the efficiency and predictability of applications for registration of NCE products under the "1+" mechanism. For companies intending to request Pre-NDA meetings with the Drug Office, please refer to the “Guidance on Pre-New Drug Application Meetings” for further details and submit a “Pre- New Drug Application Meeting Request Form” and lodge a request to the Drug Office via the Pharmaceutical Registration System (PRS 2.0). Both documents can be found in the Guidance for Industry section.
The Department of Health organized 3 briefing sessions for the Pre-NDA Meetings under the "1+" mechanism on 14, 16 and 21 January 2026 to introduce the Pre-NDA Meetings and provide guidance on the submission for meeting requests.
The 3 briefing sessions were well received and were attended by 144 representatives from pharmaceutical and consultation companies inside or outside Hong Kong, as well as scientific research institutions.
The Drug Office joined the seminar of‘Advancing Hong Kong Drug Registration: Industry-Regulator Exchange on "1+" Mechanism’ organized by the Greater Bay Area International Clinical Trial Institute (GBAICTI) and co-organized by the Hong Kong Association of the Pharmaceutical Industry (HKAPI), the China Pharmaceutical Innovation and Research Development Association (PhIRDA), and the Hong Kong Science and Technology Parks Corporation (HKSTP) on 15 April 2026. There were in-depth exchanges with industry stakeholders on the drug regulatory developments and clinical trial advancement in the Greater Bay Area, and analyzed how new drugs are introduced to Hong Kong through the "1+" mechanism.
The seminar ended with a panel discussion with guests from the PhRIDA, HKAPI, HKSTP and two pharmaceutical companies in the Chinese Mainland as well as officers of the Drug Office, and a Q&A session. More than 150 participants, including representatives from over 30 companies from the Chinese Mainland, attended the event.
22-11-2024
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.
"1+" mechanism
