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 kick started the Workshop for New Drug Applications under “1+” Mechanism on 16 June 2025. 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 90 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.
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