DH accepts applications for one-on-one pre-new drug application meetings under "1+" mechanism
The Department of Health (DH) announced today (December 22) that potential applicants for new drugs registration through the "1+" mechanism may now request one-on-one pre-new drug application (NDA) meetings with immediate effect. This service aims to further optimise the new drug registration approval process by working with the pharmaceutical industry to achieve the goals of early consultation to enhance quality and efficiency throughout the process so that registration approval can be expedited in Hong Kong. It will consolidate Hong Kong's position as an international health and medical innovation hub.
Consultation service for new drug applications under "1+" mechanism
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The introduction of the consultation service under the "1+" mechanism will enhance efficiency in processing applications. The consultation service comprises three components, namely briefing seminars, workshops and pre-NDA meetings.
There are two types of pre-NDA meetings that provide tailored services and appropriate support for applicants with different needs. These meetings help potential applicants plan their applications earlier and more comprehensively, while streamlining the submission process. Details are as follows:
- Company-oriented: Meetings are specifically for first-time applicants through the "1+" mechanism. DH professionals will provide tailored advice and guidance on applicable drug registration categories and application pathways based on the applicant company's profiles and potential registration applications; and
- Product-specific: Meetings are tailored to specific new drug registration projects. DH professionals will provide concrete advice on the supporting evidence, procedures and documentation required for the particular new drug registration.
Information on how to apply for one-on-one pre-NDA meetings has been uploaded on the "1+" mechanism thematic webpage. To encourage the industry to experience the one-on-one pre-NDA meetings, no fees will be charged for this service at this stage. The DH will actively maintain communication with the industry to gather feedback and suggestions regarding the one-on-one pre-NDA meetings.
Since March of this year, the DH has organised seven briefing seminars to brief the trade and stakeholders on the basic requirements and procedures for Hong Kong drug registration under the "1+" mechanism. The DH has also organised three workshops to provide guidance and share good practices and real-life experiences on submitting applications through the "1+" mechanism. These seminars and workshops have been well received by over 580 representatives from pharmaceutical companies, consultancy firms and research institutes, etc, in and outside Hong Kong. The DH has uploaded the detailed arrangements and briefing materials for the seminar to the thematic webpage on the "1+" mechanism. The DH will continue to organise workshops and briefing seminars as needed based on feedback from the industry.
Paving the way towards primary evaluation
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The Hong Kong Special Administrative Region (HKSAR) has implemented the "1+" mechanism since November 1, 2023, and has extended it to all new drugs from November 1 last year, including all new chemical or biological entities and new indications, and vaccines and advanced therapy products. Under the "1+" mechanism, new drugs which are supported by local clinical data and recognised by local relevant experts can be applied for registration in Hong Kong by submitting approval from the drug regulatory authority of one of the reference places (instead of two in the past).
Since the implementation of the "1+" mechanism, a total of 16 new drugs have been approved under this mechanism. Seven of them have been listed in the Hospital Authority Drug Formulary. The DH has been promoting the "1+" mechanism through different channels and so far has received more than 700 enquiries from over 180 pharmaceutical companies (including those from the Chinese Mainland and overseas).
The Chief Executive's 2025 Policy Address announced that the HKSAR Government will accelerate the reform of the regulatory system for drugs and medical devices. The DH will continue to expedite the "1+" mechanism for new drugs by piloting the priority evaluation and approval of innovative drugs as recommended by the Hospital Authority for treatment of severe or rare diseases and to accelerate patients' use of the advanced treatments. In addition, the DH will establish the Hong Kong Centre for Medical Products Regulation by the end of 2026, and will implement "primary evaluation" for new drug registration in phases beginning in 2026. These efforts will provide strong momentum for the development and market expansion of the healthcare industry in the HKSAR, the Chinese Mainland, and beyond.
The Department of Health, Photo source: news.gov.hk
