MIV-2 (Do-and-Tell) for CTGTP: Streamlining Post-Approval Change Management for Industry
Effective 15 January 2026
We are pleased to introduce our new minor variation (MIV) initiative: MIV-2 (Do-and-Tell) for Cell, Tissue and Gene Therapy Product (CTGTP), aimed to enhance post-approval change management efficiency and provide greater operational flexibility.
From 15 January 2026, companies can implement eligible administrative changes to your registered CTGTP directly and notify HSA within 6 months of the effected changes. These changes can be bundled and submitted through a single MIV-2 submission in
SHARE.
For more information on the 17 eligible MIV-2 (Do-and-Tell) changes, please refer to Part C of the revised
MIV Checklist For Class 2 CTGTP. A
Quick Guide is also available to facilitate your MIV-2 submission planning.
Thank you for your continued support and partnership.
Health Products Regulation Group
Health Sciences Authority
Industry member, Cell, Tissue and Gene Therapy Products
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