Peptide is a compound formed by linking multiple amino acids through amide bonds. It can be prepared by recombinant gene expression, biological extraction, chemical synthesis, and other methods.

Chemically synthesized peptide drugs have their own attributes in terms of preparation methods, structure validation, and quality research, thus cannot be simply classified as small molecule chemical drugs or biological products.

The guidelines analyze the special issues involved in CMC researches on synthetic peptide drugs, draw upon the practice and experience of research and evaluation of peptide drugs at home and abroad, and offer the general technical guidance for CMC researches on chemically synthesized drugs.