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.
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 expertise of the QIG can also be called upon in the assessment of medicines using these innovative technologies in regulatory submissions such as scientific advice, marketing authorisation applications and related post-authorisation lifecycle changes.
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) inspections. The group reports under the Quality Domain of EMA’s working party structure.
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