Risk-Based Biologies - CMC Flexibilities in the EU Regulatory System

摘要

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.