Regulations and systems for quasi-drugs

 In 2021, MHLW revised its approval standards for feminine care products, hair colouring products, permanent wave products, and medicated toothpastes, and issued a new notice. In addition, the standard for quasi-drug raw materials was revised as "the quasi-drug raw material specification 2021." In July 2019, PMDA revised the mockup for the application for marketing approval for quasi-drugs (cosmetics for pharmaceuticals) and added an illustration on how to treat the standard of the appended ingredients and the test method in the case where the standard is the same as the appended standard of the approved item. Along with these developments, progress has been made in improving the simplification and speed of application and examination operations. In addition, in order to facilitate the review process, a briefing for personnel in charge of the application for quasi-drug approval is held every year, and reviews are conducted based on the materials provided at the briefing sessions. However, the positioning of the materials is not clearly indicated. As a recent topic, the Council for Promoting Regulatory Reform has asked the MHLW to consider transitioning to garbage and eye washes, which are thought to have less effect on the human body, in light of the need for the transition to quasi-drugs for some of the Group III Pharmaceuticals, and asked for a conclusion within FY2026.