Global Regulatory Requirements Applicable for PROTACs
摘要
The present chapter highlights the pivotal role of global regulatory guidelines in overseeing the development, evaluation, and commercialization of PROTACs, a novel class of therapeutic agents with unique mechanisms of action. It emphasizes the importance of adhering to Good Clinical Practice (GCP), Chemistry Manufacturing and Controls (CMC) regulations, and Good Manufacturing Practice (GMP) standards to ensure the quality, safety, and consistency of PROTACs. By following these guidelines, developers can demonstrate the ethical conduct, efficacy, and quality of PROTACs, ultimately supporting their successful regulatory approval and commercialization. The chapter underscores the significance of regulatory compliance in advancing innovative therapeutic approaches for the benefit of patients worldwide.