These include innovative technologies, novel materials and devices, and digitalisation in manufacturing, in line with EMA's Regulatory science strategy to 2025.
The group 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 main working areas during 2023-24 were:
The grou's main focus for 2025 is personalised medicines.
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:
Medicine developers may email qig@ema.europa.eu to:
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.
Their declarations of interests are available in the European expert list:
The QIG's tasks include:
More information on the QIG's responsibilities, composition, procedures and activities: