Post-Marketing Commitments for Biologics Explained: Ultimate Guide to Regulatory Obligations and Compliance Mastering Post-Marketing Commitments for Biologics: Compliance-Ready Guide for Regulatory Affairs Professionals Introduction to Post-Marketing Commitments and Their Importance Post-Marketing Commitments (PMCs) are studies, surveillance activities, and reporting obligations that sponsors must undertake after a biologic or biosimilar has been approved. Regulatory agencies like the FDA, EMA, and CDSCO use PMCs to monitor long-term safety, confirm clinical benefit, and ensure ongoing risk management. These commitments can include Phase IV trials, pharmacovigilance programs, and registry-based observational studies. By 2025, PMCs have become central to biologics lifecycle management, especially as advanced…