Comparative Study on Current Regulatory Requirements for Generic Synthetic Peptide Based Drug-Device Combination Products in U.S. and Europe

Abstract

This thesis examines the regulatory frameworks for generic synthetic peptide-based drug device combination products in the U.S. and Europe, providing a comparative analysis of requirements outlined by the USFDA and EMA. Beginning with an overview of peptides, it explores historical perspectives, limitations, and therapeutic advancements. The study scrutinizes regulatory pathways, scientific considerations, and clinical pharmacological aspects for both regions. Through comparative analysis, similarities and differences in regulatory requirements are highlighted, encompassing pre-marketing considerations and post-market obligations. Additionally, the regulation of drug-device combination products, including types and regulatory bodies, was investigated. Specific focus was given to regulations governing generic synthetic peptide-containing drug-device products, considering primary modes of action based on both peptides and associated devices. In conclusion, marketing generic peptide-containing drug-device products presents a complex endeavour, primarily due to the diversity of components involved. Furthermore, notable disparities exist in the regulatory frameworks and marketing strategies employed by both regulatory agencies.