On July 22nd, the European Medicines Agency (EMA) published a draft guideline titled “Guideline on the Development and Manufacture of Oligonucleotides” (EMA/CHMP/CVMP/QWP/262313/2024-17 July 2024). This guideline addresses specific aspects of the manufacturing process, characterization, specifications, and analytical control for synthetic oligonucleotides that are not covered in the existing “Guideline on the Chemistry of Active Substances” (EMA/454576/2016).
The new guideline aims to facilitate the marketing authorization process by providing clear requirements for clinical trial applications. It encompasses considerations related to conjugation, active substances in solution, medicinal product development, oligonucleotide generics development, and personalized medicine approaches.
The public consultation period for this draft guideline begins on July 22, 2024, and ends on January 31, 2025. Stakeholders are encouraged to review and provide feedback during this period.
For more details, you can access the guideline here: Guideline on the Development and Manufacture of Oligonucleotides
For further information or request, contact us at: [email protected]
