In Japan, cosmetic products are regulated by the Pharmaceutical and Medical Device Act, which stipulates compliance requirements and defines two categories of products: cosmetics and quasi-drugs. Quasi-drugs are in between pharmaceuticals and cosmetics, having officially recognized active ingredients. At the end of 2020, the MHLW proposed amendments for the marketing approval standards of medicated oral-care products, hair dyes and permanent wave agents, which were approved and just became effective. The GMP Ministerial Ordinance and the new JSQI were also approved by the MHLW in 2021.