Following the Ministry of Food and Drug Safety’s 15 July 2021 announcement, ATT is no longer included as a required batch quality control test in MFDS biologicals standard and test-method guidelines for vaccines and other biological products. Manufacturers of MFDS-regulated vaccines and biologicals are no longer required to plan, conduct, or report ATT as a condition of batch release under the amended regulation.

The Animal-Free Safety Assessment Collaboration’s international status tracking records South Korea’s ATT requirement as “Deleted (2022),” referencing the same amendment to the Regulation on Approval and Review of Biologicals Products. No quantitative data on the number of animals, batches, or facilities affected by the deletion is available in current sourcing.

Anticipated Effects

If manufacturers replace ATT with non-animal or other quality-assurance approaches as encouraged by WHO and Animal-Free Safety Assessment Collaboration guidance, some quality-control activities for biologicals would be expected to shift toward analytical, process-validation, or in vitro methods. This is a conditional expectation; available sources do not document post-implementation data on the degree to which testing has shifted to alternative methods or on realized reductions in the number of mice and guinea pigs used for this purpose in South Korea since the deletion.

Significance Rationale

Assigned Reduces Exploitation because the amendment documents an actual, completed deletion of a previously mandatory in vivo animal test from national batch-release requirements for biological products, rather than a stated intention or future target; ATT’s removal directly eliminates a specific, defined use of mice and guinea pigs from the regulatory testing system.

Assigned Alters Legal Basis as the primary mechanism, since the amendment changes what is legally required for batch quality control of biological products by deleting ATT from the mandated test panel, rather than adjusting operational conditions within a continuing test requirement.

Assigned Moderate significance because the deletion applies across an entire national regulatory category (batch release testing for MFDS-regulated vaccines and biologicals) but addresses a single specific test rather than the broader landscape of animal testing in pharmaceutical and chemical regulation, and no quantitative data on the number of animals previously used in ATT in South Korea is available to establish the scale of this reduction. The duration and persistence of this change is not established in available sources, though no reversal, suspension, or legal challenge has been identified.