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: 

• Working parties and domains: Overview and domain concept

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 

More information on the QIG's responsibilities, composition, procedures and activities is available in the following documents: