The European Medicines Agency (EMA) has established the Quality Innovation Expert Group (QIG) to aid innovative approaches for the development, manufacture and quality control (QC) of medicines, including new technologies, digitalisation, novel materials and novel devices for patients in the European Union (EU).
The QIG, set up in September 2022, is composed of eight members with backgrounds in chemical, biological quality assessment and Good Manufacturing Practice (GMP) inspections, who report under the Quality Domain of EMA’s working party structure. The body will ensure the European medicines regulatory network maintains momentum with innovation, recognises and addresses gaps in the regulatory framework and increases predictability for innovative technology developers. The group will also be a forum for exchange and interaction within the EU regulatory network such as the EU Innovation Network, EU regulators and stakeholders such as academia and industry. Another aim will be to establish close collaboration with international partners to facilitate global regulatory convergence.
According to the EMA, to support quality control of medicines, the QIG will:
- Offer an entry point for developers to discuss innovative approaches in the development, manufacturing and/or control of medicines
- Prepare guidance documents related to innovative quality and manufacturing technologies
- Contribute to pharmaceutical quality-related workshops or training for EU assessors and GMP inspectors.
Additional tasks include horizon scanning to identify emerging innovative technologies anticipated to impact regulatory decision making in the medium to long term; then formulating appropriate regulatory responses in advance as they mature.
The group will contribute to the assessment of procedures that include these new technologies in regulatory submissions, such as scientific advice, marketing authorisation applications and relevant post-authorisation lifecycle development.
The QIG will work in line with the priorities emphasised in EMA’s Regulatory Science Strategy to 2025, in which the regulatory body identified key goals and core recommendations for human medicines. The five key goals of this strategy are:
- catalysing the integration of science and technology in medicines’ development
- driving collaborative evidence generation – improving the scientific quality of evaluations,
- advancing patient-centred access to medicines in partnership with healthcare systems
- addressing emerging health threats and availability/therapeutic challenges
- enabling and leveraging research and innovation in regulatory science.
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