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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Video: Towards Global Deletion of the ATT

An overview of the work that has been undertaken and is still needed to delete the obsolete, animal-based Abnormal Toxicity Test (ATT) from biologicals product testing worldwide. .

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Workshop report: Elimination of ATT and TABST

Read the full report from our March 2019 international workshop, available now in the journal Biologicals.

 

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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

Our Collaborators

Workstream Coordinator

Laura Viviani

Laura Viviani

HSI Regulatory Science Advisor,
Research & Toxicology Department

Email: lviviani@hsi.org