SEOUL—South Korea’s Ministry of Food and Drug Safety has introduced an amendment to its Biologicals standard and test method guidelines, and will no longer require the Abnormal Toxicity test. The outdated method was carried out for batch quality control of pharmaceutical and biological products, using mice and guinea pigs. Humane Society International/Korea welcomed the ministry’s decision to end this obsolete animal test for biological products.
The World Health Organization guidelines recommended the removal of the Abnormal Toxicity Test in 2018 and it is no longer required in the European Union, the United States and Canada. In Japan and India the test can be waived for some products.
The test was originally introduced in the 1950s using mice and guinea pigs to detect external non-specific contaminants in pharmaceutical and biological products and has remained a standard despite mounting scientific evidence questioning its reliability and value to the detection of quality and safety issues.
Borami Seo, HSI/Korea’s senior policy manager said “We welcome this much-awaited amendment that does away with an obsolete animal test. This test was required for regulatory purposes despite evidence showing its lack of scientific value. Korea has a demonstrated capacity to adopt and refine rapidly advancing technologies. We hope that with this important step, Korea will move even faster, showing its commitment to developing new technologies and reforming regulatory guidelines with non-animal methods.”
Introduced in December 2020, the ‘Act on the Promotion of Development, Dissemination and Use of Alternatives to Animal Testing Method’ urges governments to collaborate and coordinate to provide proactive measures in advancing science without animal use. Passage of this bill will provide a legal basis for governments and industries to keep pace with advancing science and enable the global regulatory community to move towards adopting non-animal approaches. In addition, it will encourage regular reviews of obsolete tests for elimination from regulatory test guidelines.
HSI received a grant from the Bill & Melinda Gates Foundation to work with regulatory authorities and industry stakeholders across the globe to eliminate or replace redundant animal regulations for human and veterinary products.
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Media Contact: Borami Seo, bseo@hsi.org
