EMA sets up expert group on medicine innovation

The European Medicines Agency (EMA) has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufacture, and quality control of medicines for the benefit of patients in the EU. These include new technologies, digitalisation, novel materials and novel devices.

The role of the QIG is to ensure that the European medicines regulatory network keeps pace with innovation, identifies and addresses gaps in the regulatory framework and increases predictability for developers of innovative technologies.

The group will also be a forum for exchange and interaction within the EU regulatory network, as well as between EU regulators and stakeholders such as academia and industry. As the development and manufacturing of medicines is global in nature, the QIG also aims to establish close collaboration with international partners to facilitate global regulatory convergence.

Other tasks of the group include horizon scanning to identify forthcoming innovative technologies and proactively formulating appropriate regulatory responses to each of them as they mature. The EMA says the expertise of the QIG can also be called upon in the assessment of medicines using these innovative technologies in regulatory submissions.

The Quality Innovation Expert Group was set up in September 2022 and is composed of eight members with a background in chemical, biological quality assessment and Good Manufacturing Practice (GMP).