Regulatory Briefing Session on “1+” Mechanism and Enhancement Measures
The enhancement measures of the “1+” mechanism came into effect on 1st May 2024. To provide a comprehensive understanding of the new pathway and its associated measures, the HKAPI Regulatory Working Group recently co-organized a briefing session with the Department of Pharmacology and Pharmacy of the University of Hong Kong.
The briefing session was held on 30th April 2024, with a total of 140 attendees joining in person or via Zoom. They are from local, regional, and global teams of member companies, as well as a selected group of HKU students.
The event commenced with an opening speech by Ms. Sabrina Chan, Senior Executive Director of HKAPI. Sabrina welcomed distinguished guests from the Drug Office and attending members. She also briefed about the background and objectives of the event.
Mr Raphel Yeung, Senior Pharmacist of the Drug Office, then 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”. His presentation shed light on the key changes and their implications for the drug application process.
The briefing session concluded with a Q&A session, which Prof Aviva Chow, Assistant Professor of the Department of Pharmacology and Pharmacy of HKU, and Ms Linda Chan, Lead of the Regulatory Working Group, helped moderate. Participants posed numerous thought-provoking questions, which were answered by Mr Frank Chan, Assistant Director of Health of the Drug Office, and Raphael
To ensure that all members’ questions were addressed, the working group recorded unanswered questions for future communication with the Drug Office team.
Overall, the briefing session provided an invaluable platform for members to stay updated on the latest policy developments, exchange knowledge and ideas, and most importantly, engage directly with the Drug Office team. The HKAPI office extends our gratitude to everyone who participated and contributed to the briefing session.
Training materials are now available in the Member’s Area.
