(Health Korea News / Yoo Ji-in) The government is starting to develop testing methods to replace laboratory animals used for quality control required for vaccine shipment approval.
The Ministry of Food and Drug Safety announced on the 18th that it plans to invest 11.64 billion won from next year to 2029 to carry out a project to ‘establish a basis for alternative evaluation technology for vaccine quality control animals’. The goal of this project is to develop a test method that can replace laboratory animals used for quality control required for shipment approval of botulinum and DTaP (diphtheria, tetanus, and pertussis) vaccines.
The Ministry of Food and Drug Safety plans to establish and distribute internationally harmonized testing methods through the verification process of alternative animal testing methods for vaccine quality control, thereby realizing the value of respect for life and supporting the global expansion of domestically produced vaccines.
An official from the Ministry of Food and Drug Safety said, “We plan to spend 1.838 billion won next year to conduct verification of the botulinum toxin mechanism in vivo, including a test tube implementation test method, detoxification test method, and potency test method, by 2026.”
The Ministry of Food and Drug Safety has decided to lead the way in regulating alternative animal testing methods, including reflecting them in the World Health Organization (WHO) vaccine-related technical documents through international joint research with foreign organizations, including those in Europe, starting in 2027. In 2028, a practical technological self-reliance environment will be created through self-production and supply of reaction reagents (antibodies, etc.) used in the test method, and in 2029, the existing animal test method will be deleted and an alternative animal test method will be introduced in the ‘Biological Products Standards and Test Methods’ notice. We plan to reflect it.
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