According to the agency, the proposed guidelines would address aspects of peptide and oligonucleotide manufacturing, characterisation, specification and analytical control “not covered in the Guideline on the Chemistry of Active Substances (EMA/454576/2016) and Chemistry of Active Substances for Veterinary Medicinal Products (EMA/CVMP/QWP/707366/2017).”
Source:
RAPS.org: Regulatory News
EMA: Concept Paper on Synthetic Peptides and Concept Paper on Synthetic Oligonucleotides
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