BIOLOGICALS PRODUCTION & RELEASE TESTING
Removing and replacing obsolete animal tests from biologicals regulation
Today, strict quality control standards for biologicals production and release testing enable use of innovative approaches that can fully replace animal testing and ensure batch-to-batch consistency, as well as high quality, safety and efficacy. However, some countries continue to regard animal-based testing as a gold standard, leading to the continued use of millions of animals each year. We’re working to bring stakeholders together to overcome economic, technical, regulatory and other barriers to the removal, waiving and replacing of obsolete animal testing requirements from biologicals regulatory frameworks globally.
New Assays Implementation and Acceptance
We’re supporting dialogue among international and national regulatory and industry stakeholders to develop plans to implement innovative non animal tests and promote global regulatory alignment.