Pharmacists and companies that hold Certificates of Suitability for European Pharmacopoeia (CEP) are being asked to review and provide feedback on new draft quality standards for 15 important medicines. These draft standards, published by the European Directorate for the Quality of Medicines & HealthCare (EDQM), will soon become official rules that manufacturers must follow to ensure the safety and quality of these drugs. The 15 medicines affected by these new draft standards are: Cyproterone acetate, Deferasirox, Donepezil hydrochloride, Fluoxetine hydrochloride, Heparin calcium, Heparin sodium, Hydrocortisone, Ipratropium bromide monohydrate, Macrogols, Potassium citrate monohydrate, Riboflavin sodium phosphate hydrate, Sodium nitroprusside dihydrate, Thiocolchicoside crystallised from ethanol, and Thiocolchicoside hydrate. Companies based in Europe should send their comments through their country’s national pharmacopoeia authority, while those outside Europe can submit feedback directly to the EDQM HelpDesk. The deadline for submitting comments is September 30. In addition to these updates, the EDQM has also introduced important changes earlier this year to support safer and more modern testing methods in the pharmaceutical industry. One key update requires manufacturers to replace animal-based tests for detecting contaminants like bacteria with safer, animal-free alternatives such as the monocyte-activation test or the bacterial endotoxins test (BET). This change helps protect animal welfare while maintaining high safety standards for medicines. Another new rule, introduced in January, is a guide to help manufacturers make better quality decisions as they move towards digital record-keeping and automation. These changes reflect the EDQM’s efforts to improve the safety, efficiency, and sustainability of medicine production in Europe.