Regulatory Considerations for API Manufacturing in the EU: Ensuring Compliance and Supply Chain Resilience

The EU has established regulatory guidelines for active pharmaceutical ingredients (APIs) used in medicines to ensure their quality and safety. Compliance with the Good Manufacturing Practice (GMP) guidelines is compulsory for all API manufacturers and importers, including registration with a national authority. Inspections are carried out by national authorities, and the results are posted in the publicly-accessible EudraGMDP database. The authors propose additional justifications for formulated API approaches for oligonucleotide APIs. Discussion with regulators is welcomed to modernize the guidelines.