Regulations and systems for quasi-drugs

No progress
MHLW issued a notice of concern regarding the examination of approval of pharmaceutical shampoos, pharmaceutical rinses, and pharmaceutical soaps, and set out its examination guidelines. In July 2019, PMDA revised its application for manufacturing and marketing approval for quasi-drugs and added illustrations of how to treat applied products with the same standards and test methods as those of the attached specifications in the approved products. 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.


  • For quasi-drugs deemed to be identical and similar to already approval quasi-drugs, the review period should be shortened.
  • When changing the approach to the review, it should be announced at the briefing session for practitioners applying for quasi-drug approval and communicated to the applicants in an easy-to-understand manner through careful explanations.