Skip to main content Skip to search Skip to main navigation

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)

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be Interested in the Following Articles:

What are the quality requirements for pharmaceutical gases?

What are the quality requirements for pharmaceutical gases?

You can view the answer here:
Read more
EMA: Update on the Guideline “Stability Testing for Variations”

EMA: Update on the Guideline “Stability Testing for Variations”

The EMA has updated the guideline on stability testing for variations (Revision 3, applicable from 15 January 2026).
Read more
EU: Proposal for Simplification of Medical Device Rules

EU: Proposal for Simplification of Medical Device Rules

The European Commission has proposed targeted reforms to simplify the Medical Device Regulation (Regulation (EU) 2017/745, MDR) and the In Vitro Diagnostic Regulation (Regulation (EU) 2017/746, IVDR) and to address structural implementation challenges.
Read more
EU: Proposal for a European Biotech Act

EU: Proposal for a European Biotech Act

The European Commission has presented a proposal for a European Biotech Act aimed at strengthening Europe’s biotechnology potential and accelerating the translation of innovation from the laboratory to the market.

Read more
EMA: Concept Paper for the Revision of Annex 3 on Radiopharmaceuticals

EMA: Concept Paper for the Revision of Annex 3 on Radiopharmaceuticals

The EMA has published a concept paper outlining a future revision of Annex 3 (Manufacture of Radiopharmaceuticals) of the EU GMP Guidelines. The paper was developed in collaboration with PIC/S and adopted by the GMDP Inspectors Working Group (IWG) at its November meeting.

Read more
EMA: Q&A on QP Certification Without Physical EU Import

EMA: Q&A on QP Certification Without Physical EU Import

The EMA has published a new Q&A addressing QP certification for batches that are neither manufactured within the EU/EEA nor intended for the EU/EEA market, and that are not physically imported into the EU/EEA.

Read more
Previous
Next