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

The QIG can support the development and registration of innovative technologies and products, by clarifying the regulatory requirements for manufacturing and control early on for stakeholders. 

The group's work helps to avoid regulatory barriers and adapt regulatory guidance while ensuring products meet the required quality, safety and efficacy standards.

The group's 2024 priority topics are:

  • Process models
  • Platform technologies

Its 2023 priority topics were:

  • Decentralised manufacturing
  • Continuous manufacturing of biologicals or end-to-end continuous manufacturing
  • Digitalisation and automation of manufacturing and control

Stakeholder engagement

The QIG holds listen-and-learn focus group meetings with stakeholders from industry, academia and international regulators to hear about the regulatory challenges developers face in relation to innovative products, processes, control strategies and facilities, and to identify potential solutions together. 

More information and meeting reports: 

The QIG aims to provide coherent advice to developers during the product development lifecycle. It can do this during:

  • Regulatory procedures, such as scientific advice or protocol assistance, initial marketing authorisation applications or post-authorisation procedures 
  • Informal information-sharing meetings with individual developers, which can help identify potential regulatory issues in development programmes 

Medicine developers may email qig@ema.europa.eu to: 

  • Request advice from the QIG 
  • Discuss plans for applying for an EMA scientific advice procedure on a topic covered by the QIG work programme

Composition

The QIG consists of experts from the EU regulatory network with expertise in the quality assessment of chemical or biological medicines (including advanced therapy medicinal products) or good manufacturing practice (GMP) inspections. The QIG may involve ad hoc experts on certain topics.

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

  • Marcel Hoefnagel (Chair)
  • Giampiero Lorenti 
  • Leticia Martinez-Peyrat 
  • Christina Meissner 
  • Silke Schüle
  • Barbara Stubbe 
  • René Thürmer 
  • Marcos Timon

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

Mandate and work programme

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 relevant experts the European medicines regulatory network, international regulators, industry and academic associations 
  • Preparing regulatory guidance on innovative quality and manufacturing technologies
  • Contributing to training for EU assessors and GMP inspectors 

More information on the QIG's responsibilities, composition, procedures and activities:

Provisional mandate, objectives and rules of procedure for the Quality Innovation Group (QIG)

3-year work plan for the Quality Innovation Group 2024-2026

Contact point

Related documents

How useful do you find this page?