EMA has published a final guideline on synthetic peptide development and manufacture. The text will take effect 1 June 2026.

The agency created the text to share information about the manufacturing process, characterization, specifications, and analytical control that are specific to synthetic peptides and not covered in broader documents about the chemistry of active substances. EMA also included information about conjugation, developing synthetic peptides using biological peptides as references, and other topics.
 
The final guideline has the same structure as the draft EMA released for consultation in 2023. Most of the document focuses on the active substance, with subsections addressing the manufacture, control, and stability of synthetic peptides....[EMA]