How the FDA, ICH, and EMA Regulate Peptide and Protein Drug Quality — a Complete Overview

Peptide and protein drugs now account for approximately 25% of the global pharmaceutical market. The FDA, ICH (International Council for Harmonisation), and EMA (European Medicines Agency) have each established specific guidelines for the analysis, stability testing, and quality control of peptide and protein therapeutics. The review summarizes these frameworks and advocates for tailored bioanalytical workflows for each individual peptide or protein drug, since each has unique stability and characterization requirements.

Regulatory review article summarizing guidelines from the FDA, ICH, and EMA regarding the analysis, stability testing, quality control, and formulation requirements for therapeutic peptides and proteins.

As peptide drugs explode in popularity (from insulin to semaglutide and beyond), understanding how they're regulated ensures quality and safety. This review provides a comprehensive overview of the regulatory landscape across the three major regulatory bodies, which is essential for drug developers, compounding pharmacies, and anyone evaluating peptide drug quality.

With GLP-1 drugs driving record pharmaceutical revenues and hundreds of peptide drugs in development pipelines, regulatory quality standards have never been more important. This review arrives at a critical time when compounding pharmacy-made peptides are under intense scrutiny (e.g., compounded semaglutide and tirzepatide). Understanding the regulatory framework helps distinguish between properly manufactured peptide drugs and those that may lack adequate quality testing.

This is a review of existing regulatory frameworks, not an experimental study. Guidelines are inherently evolving documents — some details may change as regulators update requirements. The review focuses on the three major Western regulatory bodies and may not cover regulatory frameworks in other major markets (e.g., China's NMPA, Japan's PMDA) in equal depth.