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Peptide Approval Process

Meaning

The Peptide Approval Process refers to the specific regulatory pathway and requirements established by national health authorities, such as the FDA or EMA, for a synthetic or naturally derived peptide therapeutic to be legally marketed and prescribed. This rigorous, multi-phase process mandates extensive preclinical testing for safety and toxicology, followed by sequential clinical trials (Phases I, II, and III) to demonstrate efficacy and confirm safety in human subjects. Due to their nature as biological products, peptides often follow the Biologics License Application (BLA) pathway, demanding comprehensive data on manufacturing consistency and immunogenicity. This structured regulatory scrutiny ensures the therapeutic integrity and public safety of these complex molecules.