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Health Sciences Authority
Regulatory Updates

MIV-2 (Do-and-Tell) for CTGTP: Streamlining Post-Approval Change Management for Industry

Audiences

Industry member

Product type

Cell, Tissue and Gene Therapy Products

15 January 2026

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

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 [PDF, 428 KB]. A Quick Guide [PDF, 205 KB] 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

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