EMA Develops A Quality Control Group To Aid Drug Development

To support innovative approaches for the development, manufacture, and quality control (QC) of medicines, along with new technologies, digitalization, novel materials, and novel devices for patients in the European Union, the European Medicines Agency (EMA) formed the Quality Innovation Expert Group (QIG).

Eight members of the QIG, which was established in September 2022 and reports to the Quality Domain of EMA’s working party organisation, have backgrounds in chemical, biological, and good manufacturing practise (GMP) inspections. The organisation will make sure that the European drug regulatory network maintains its innovative momentum, identifies and fills in regulatory framework gaps, and gives new technology developers more predictability. The group will serve as a forum for discussion and engagement among EU regulators, stakeholders, including academia and industry, and the EU regulatory network, such as the EU Innovation Network. To assist the convergence of worldwide regulatory standards, close coordination with foreign partners will be another goal.

The EMA states that the QIG will do the following to support quality control of medicines:

• Provide a forum for developers to debate novel approaches to drug development, production, and/or control.
• Create instructions for cutting-edge production and quality technologies.
• Participate in training sessions or workshops on pharmaceutical quality for EU evaluators and GMP inspectors.

Identifying novel emerging technologies that are expected to have an impact on regulatory decision-making in the medium to long term is another responsibility, as is developing suitable regulatory reactions in advance as these technologies develop.

The group will contribute to the evaluation of processes used in regulatory submissions that contain these novel technologies, such as scientific recommendations, marketing authorization applications, and pertinent post-authorization lifecycle development.

The regulatory body’s Regulatory Science Strategy to 2025, which outlined important objectives and fundamental suggestions for human pharmaceuticals, will serve as the foundation for the QIG’s activities. These are the strategy’s top five objectives:

• Promoting the integration of science and technology in the creation of pharmaceuticals
• Promoting cooperative evidence development and raising the scientific calibre of assessments
• Partnering with healthcare systems to increase patient-centered access to medications
• Addressing new risks to health, as well as issues with accessibility and treatment
• Promoting and making use of regulatory science research and innovation.