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News: EMA

EMA: Work Plan for the Quality Innovation Group

The EMA has published the three-year rolling work plan for the Quality Innovation Group (QIG) for the period 2025-2027. QIG supports the translation of innovative approaches to the design, manufacture and quality control of medicines.

The QIG helps to advance international harmonisation through support to relevant ICH guidelines, and to consolidate learnings/support knowledge management for strategic topic areas.

To the activities ongoing/to be finalised in 2025/2026 belong:

EU Guidance documents, New, QIG lead:

  • QIG Preliminary Considerations on Pharmaceutical Process Models

EU Guidance documents, New, QIG specialised input:

  • Questions and Answers on 3D printing
  • Questions and Answers on Decentralised Manufacturing
  • EU GMP Annex 11 on Computerised Systems

Source:

EMA: 3-year rolling work plan for the Quality Innovation Group (QIG)

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