Regulatory Briefing Session on Extending “1+” Mechanism
The “1+” mechanism has been extended to all new drugs on 1st November 2024, as one of the measures to enhance drug approval mechanism in “The Chief Executive’s 2024 Policy Address”. On 22nd November 2024, 140 participants from the HKAPI member companies attended a briefing seminar on the latest enhancement of the mechanism by the Drug Office, Department of Health.
Ms. Sabrina Chan, Senior Executive Director of HKAPI, kicked off the event by addressing the importance of good regulatory practice.
Mr. Frank Chan, JP, the Assistant Director of Health (Drug), stated collaboration between the Drug Office and industry has been highly valued and envisioned betterment of Hong Kong drug regulatory framework in the opening speech.
Mr. Raphael Yeung, Senior Pharmacist of the Drug Office, presented an overview of the “1+” mechanism implementation and its extension. Mr. Alan Ng and Ms. Emily Lau, members of the HKAPI Regulatory Affairs Working Group, facilitated participants to raise questions enthusiastically. Mr. Yeung responded to the questions and enhanced participants’ understanding of the mechanism.
It is crucial to have an efficient regulatory system. The briefing session not only updated members on the recent drug approval mechanism, but also strengthened communications and collaborations between the industry and the drug regulatory body.
Training materials are now available in the Member’s Area.
