Pharmaceutical companies and regulatory agencies strive to foster scientific excellence in drug development and evaluation so that members of the public can access the high-quality medicines that they need. Recent European Medicines Agency (EMA) approvals for COVID-19 vaccines highlight those organizational accomplishments and showcase the application of risk-based chemistry, manufacturing, and controls (CMC) flexibilities that are embedded within the European Union (EU) regulatory system. Many of the CMC flexibilities outlined herein were established for PRIME (priority medicine), a scheme that…