On 12 October 2023, the European Medicines Agency (EMA) published the draft Guideline on the Development and Manufacture of Synthetic peptides. In addition to the current lack of specific guidelines, EMA cited increased industry interest in developing peptide medicines as a motivation for developing the proposed guidelines. At SciencePharma we are always up to date and willing to participate in pharmaceutical industry-relevant public consultation.
The proposed guideline clearly states quality aspects of peptide manufacturing, characterisation, specification, and analytical control not covered in the Guideline on the Chemistry of Active Substances and Chemistry of Active Substances for Veterinary Medicinal Products.
Moreover, the draft guidance also contains requirements and considerations related to conjugation, medicinal product development, synthetic peptides development using biological peptides as European reference medicinal products, and clinical trial applications.
The document has been submitted for public consultation and the comments will be collected until April 30, 2024. Stakeholders from ICH member countries/regions may submit comments to the relevant regulatory authorities, noting the comment deadline indicated under the draft Guidance. This guideline, for clarity, has been prepared in accordance with the structure agreed for the quality part of the dossier for human medicinal products.
Our goal at SciencePharma is excellent knowledge of current guidelines. We always stay up to date with the upcoming changes and actively participate in their consultations! If you want to develop a peptide drug product, SciencePharma team will help you with all quality aspects of the development and registration of such a product.