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.

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Global regulatory alignment

We’re stimulating dialogue among national authorities, industry and other stakeholders to overcome barriers to deletion of obsolete animal tests from vaccine regulations. Our roadmap shows our global strategy and approach.

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Accelerating Global Deletion of the Abnormal Toxicity Test

Overview, presentations and proceedings of the AFSA/EFPIA Workshop 2021

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Meet our collaborators

Get to know our partners and funders who are supporting these regulatory harmonization efforts.

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Our Collaborators

Workstream Coordinator

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