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Regulatory Briefing Session on CMPR and "1+" Mechanism

The government recently announced the roadmap for the Hong Kong Centre for Medical Products Regulation (CMPR). To help members understand this new institution, the HKAPI Regulatory Affairs Working Group held a workshop on July 10, 2025, focusing on the CMPR’s strategic plan and the “1+” mechanism.

Over 100 HKAPI members attended the briefing session.

Ms. Sabrina Chan, Senior Executive Director of the HKAPI, opened the session by highlighting the importance of the partnership between the Department of Health (DH) and the Association in supporting submission and review practices. Mr. Lot Chan, Assistant Director of Health, then presented the CMPR’s strategic plan with timelines and scope of work, emphasising the importance of collaboration.

Mr. Ken Poon, a pharmacist from the Drug Office, provided updates on the “1+” mechanism, including application requirements and practical tips for submitting new chemical or biological entity applications. The event concluded with a Q&A session featuring Mr. Michael Yim and Mr. Raphael Yeung from the Drug Office, who addressed participants’ questions.

Ms. Ivy Ting and Mr. Thomas Lam, representatives from the Regulatory Affairs Working Group, helped facilitate the Q&A Session.
Representatives from the Department of Health and the HKAPI Regulatory Affairs Working Group took a group photo during the event.

Over 100 HKAPI members attended, and feedback was overwhelmingly positive. Many found the workshop to be a valuable opportunity to engage with the DH and learn about recent developments. With the success of the event, we would like to thank Mr. Frank Chan, Assistant Director of Health (Drug) at the DH, and his team for their support.

We are looking forward to working together in the future.

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