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 European Union (EU). These include, but are not limited to, new technologies, digitalisation, novel materials and novel devices, in line with the priorities highlighted in EMA’s Regulatory Science Strategy to 2025.
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. Considering that 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…
