Regulatory Intelligence Sharing
Driven by continuous dialogue with the Department of Health (DH) regarding pressing industry issues and the insights gathered through ongoing Regulatory Intelligence (RI) surveys, the HKAPI Regulatory Affairs Working Group (RAWG) hosted a “Regulatory Intelligence Sharing” session on 9 March 2026.
RAWG Lead Ms Linda Chan delivered the opening remarks, setting the stage for a deep dive into regulatory recent regulatory updates and key developments. RAWG member Ms. Emily Lau then presented detailed NCE and CORP approval timelines, and highlighted key observations drawn from the RI survey.
Building on these insights, RAWG members Mr Alan Ng and Mr Teddy Lau shared best practices and intelligence regarding NCE and CORP submissions.
Shifting the focus to future policy directions, Linda and RAWG member Ms Sharon Fung provided a heads-up on the industry’s proposal for data exclusivity and outlined key updates regarding the implementation of ICH guidelines.
Following the presentations, RAWG members facilitated an interactive breakout workshop to collect feedback from the industry on the draft DH guidelines for primary evaluation and ICH implementation. The RAWG will consolidate all feedback and present them to the DH team for further discussion.
To conclude the event, Ms Sabrina Chan, Senior Executive Director of HKAPI, thanked the attendees for their active participation and insights, which helped make the session a resounding success.
Training materials are now available in the Member’s Area.
