Quality Innovation Group

The Quality Innovation Group (QIG) supports the translation of innovative approaches to the design, manufacture and quality control of medicines for the benefit of patients.

These include innovative technologies, novel materials and devices, and digitalisation in manufacturing, in line with the Regulatory science strategy to 2025.

This is an operational expert group within the quality domain.

It consists of experts with a background in quality assessment of chemical or biological medicines (including advanced therapy medicinal products) or good manufacturing practice (GMP) inspections.

For more information, see: 

The QIG's tasks include: 

  • providing a point of entry for developers to discuss innovative approaches in the development, manufacturing and/or control of medicines; 
  • contributing to the assessment of procedures that include these new technologies; 
  • identifying new technologies expected to impact regulatory decision making in the medium to long term; 
  • engaging with ad hoc experts and academia with the relevant expertise; 
  • preparing guidance documents pertaining to innovative quality and manufacturing technologies; 
  • liaising with related working parties/groups and other innovation groups such as the EU Innovation Network
  • contributing to pharmaceutical quality-related workshops / training for EU assessors and GMP inspectors; 
  • liaising with relevant stakeholders, such as international regulators, industry and academic associations. 

Mandate and work programme 

The QIG's mandate is available below:

EMA will publish the 2023 work plan as soon as available.

Composition

The QIG is composed of eight core experts, nominated from the list of European experts and adopted by the CHMP and CVMP, taking into consideration the best available expertise needed to deliver its commitments. The QIG may involve ad hoc experts on certain topics. 

The current members are listed below, in alphabetical order of surname.

Their declarations of interests are available in the European expert list: