Establishment of alternatives to animal testing

The promotion of alternative method to animal experiment for the pharmaceutical application is of great interest to cosmetics companies, both European and Japanese, on the Japanese market. However, no new guidance has been issued since 2023 on alternative methods that can be used for regulatory filings. There are also testing methods that have limited coverage even with the existing guidance, and the hurdles for introducing cosmetic ingredients that are widely used in Europe to Japan remain high. In 2023, the International Cooperative Initiative on Safety of Cosmetics (International Collaboration on Cosmetics Safety: ICCS) was launched, and activities are being carried out with an emphasis on promoting the introduction of next-generation risk assessments (Next Generation Risk Assessment:NGRA) that do not rely on animal testing. However, discussions on NGRA and new safety assessment methods (New Approach Methodologies: NAMs) among Japanese regulators and on future administrative use are still in the very early stages.