Vaccines and Biologics

The Consortium works to replace the use of animals in the development and regulatory testing of human and veterinary vaccines, antitoxins, and other biologics. To advance progress on these issues, Consortium members work with many regulatory agencies and standards organisations, including the European Directorate for the Quality of Medicines and HealthCare (EDQM), the US Food and Drug Administration (FDA), the US Department of Agriculture, the US Pharmacopeia, India’s Central Drugs Standard Control Organization, and the Indian Pharmacopoeia Commission. Many of the Consortium’s efforts in this area originate in the EU as the successful validation of test methods that replace or reduce animal use in required procedures and that have been integrated into the European Pharmacopoeia. Once humane test methods have found regulatory approval in one region, the Consortium engages with these and other stakeholders to ensure that testing policies and official methods are revised and harmonised internationally.