ATMP

​HM4: Revision of the EU Variation Regulation – Continuing innovation in lifecycle management

By 2025-11-18T09:55:00

Kora Doorduyn-van der Stoep

Key points:

  • Regulation (EU) 2024/1701 entered into force on 1 January 2025; revised classification guidelines apply from 15 January 2026
  • Procedural changes include annual Type IA updates, super-grouping and mandatory worksharing
  • Classification guidelines introduce risk-based downgrading, greater alignment between chemical and biological products, and new regulatory tools such as post-approval change management protocol (PACMP) and pharmaceutical product lifecycle management (PLCM)

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