Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing and Controls
Chapter 2: Regulatory Perspective on Synthetic Peptides in Europe
Published:16 Aug 2019
Synthetic peptides are of increasing importance as a class of substances used in medicinal products and the number of applications for marketing authorization has increased steadily in recent years. Based on European quality guidelines, international quality guidelines and European Pharmacopoeia (Ph. Eur.) requirements, it is discussed which data are relevant for synthetic peptides. The requirements for both marketing authorization applications and for clinical studies are addressed.