EMA: Scientific Guideline on Development and Manufacture of Synthetic Peptides
The EMA has published the final version of the scientific guideline „Development and manufacture of synthetic peptides“.
This guideline addresses specific aspects regarding the manufacturing process, characterisation, specifications and analytical control for synthetic peptides which are not covered in the Guideline on the Chemistry of Active Substances (EMA/454576/2016) or Chemistry of Active Substances for Veterinary Medicinal Products (EMA/CVMP/QWP/707366/2017). It also contains requirements and considerations related to conjugation, to medicinal product development, to synthetic peptide development using biological peptides as European reference medicinal product, and to clinical trial applications (human products only).
From an analytical and regulatory perspective, peptides are interesting since they present a link between products derived from biotechnology and small molecular chemical compounds. Furthermore, synthetic peptides are fully or partially excluded from the scope of ICH Q3A/B (VICH GL10/GL11), ICH Q6A/B (VICH GL39/GL40) and ICH M7 (EMA/CVMP/SWP/377245/2016).
The guideline will come into effect on 1 June 2026.
Source:
EMA: Development and manufacture of synthetic peptides - Scientific guideline
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