Europe Now Has a Dedicated Guideline for Synthetic Peptides

Until recently, synthetic peptides in the European Union were assessed largely under general guidance written for chemical active substances. The European Medicines Agency (EMA) has now adopted a dedicated document: the Guideline on the development and manufacture of synthetic peptides (reference EMA/CHMP/CVMP/QWP/367182/2025).

What the guideline covers

According to the EMA, the guideline addresses aspects of the manufacturing process, characterisation, specifications and analytical control of synthetic peptides that are not covered by the existing guideline on the chemistry of active substances. It also includes considerations on conjugation and on medicinal product development.

How it was developed

The EMA's document history shows a staged process:

• a concept paper, open for consultation from September to December 2022;
• a draft guideline, published in October 2023 and open for consultation until April 2024;
• the adopted guideline, first published on 9 December 2025, with a legal effective date of 1 June 2026;
• an overview of the comments received on the draft, published in May 2026.

Why it matters beyond medicines

The guideline applies to medicinal products, not to materials supplied for laboratory research. It is nonetheless a useful benchmark. It reflects the European regulator's current view on which characterisation and control data matter for synthetic peptides — the same categories of information (identity, purity, related impurities, specifications) that a laboratory should look for in a certificate of analysis.