Quality Innovation Group

The Quality Innovation Group (QIG) is an operational expert group set up to support the translation of innovative approaches to the design, manufacture and quality control of medicines, to bring new therapies and help improve the supply of existing medicines to patients.
CorporateInnovation

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

For more information, see:

Role

The group supports the development and registration of innovative technologies and products. It does so by engaging with stakeholders to provide early clarification on the regulatory requirements for manufacturing and control.

Its work work helps to avoid regulatory barriers and adapt regulatory guidance. It also ensures products meet the required quality, safety and efficacy standards.

The group'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 

Mandate and work programme

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

Reference Number: EMA/619783/2022

English (EN) (169.58 KB - PDF)

First published:
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3-year rolling work plan for the Quality Innovation Group (QIG) 2026-2028

Reference Number: EMA/326306/2025

English (EN) (297.16 KB - PDF)

First published:
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QIG working areas

The group's main working areas during 2023-25 were:

  • Continuous manufacturing of biologicals and end-to-end continuous manufacturing
  • Decentralised manufacturing
  • Pharmaceutical process models
  • 3D printing
  • Digitalisation and automation of manufacturing and control
  • Manufacturing platform technologies

In 2026, the group will continue working on these topics and will also focus on advancing manufacturing technologies that support sustainability.

For more information, see the QIG 2026-28 workplan in the 'Mandate and work programme' section of this page.

Stakeholder engagement

Contribution to regulatory procedure assessments

Assigned QIG experts can participate in the primary assessment or peer review processes for certain regulatory procedures, such as:

  • Scientific advice or protocol assistance
  • Initial marketing authorisation applications - as part of the assessment team and to provide input on inspections
  • Post-authorisation procedures (i.e. variations, line extensions) - in reviews and inspections

Individual meetings with medicine developers

Individual (1-to-1) meetings between QIG and medicine developers should occur early in product development, before seeking EMA's scientific advice. During these meetings, developers can also discuss their plans to apply for scientific advice on a QIG-related topic.

These meetings serve to discuss and identify solutions related to potential regulatory, technical, and / or scientific challenges within the scope of the QIG's workplan.

On an exceptional basis, individual meetings may occasionally include site visits when these are relevant for reviewing the technology.

The meetings are free-of-charge and held virtually. Site visits can take place virtually or on site.

Medicine developers interested in a 1-to-1 meeting with the QIG, on topics under this group's remit, should send a request via email at QIG@ema.europa.eu. 

The request should include the following information:

  • Short summary of the advanced manufacturing technology in development
  • Scientific and regulatory challenged they are facing
  • Proposed solutions to these challenges for discussion with the group

The group reviews the application and confirms if the topic falls under its remit. Once it is confirmed, applicants should also provide a briefing document and any supporting materials at least 15 days before the meeting takes place.

Briefing Document for Quality Innovation Group (QIG) 1-to-1 meeting

English (EN) (132.38 KB - DOCX)

First published:
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Listen-and-learn focus group meetings

Stakeholders from industry, academia and international regulators can participate in listen-and-learn focus group meetings. 

These meetings aim to:

  • understand the scientific and regulatory challenges developers face with innovative manufacturing processes, control strategies and facilities;
  • work together to identify potential solutions and follow-up actions.

Select the expandable panel below to find a list of event pages on listen-and-learn focus group meetings, including meeting reports and video recordings:

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)
  • Leticia Martinez-Peyrat
  • Christina Meissner
  • Silke Schüle
  • Barbara Stubbe
  • René Thürmer
  • Marcos Timon
  • Ciara Turley
  • Silvia Volg

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

Contact point

You can contact the QIG at qig@ema.europa.eu.

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