Regulations and systems for quasi-drugs

No progress
The 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 presented a mock-up on how to treat products with the same standards and test methods as those of the attached specifications of approved products. These developments are expected to lead to improvements in the quasi-drug review system, but simplification and acceleration of the application and review process have not been assured. 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 instance, a new item is approved because it is identical to an already approved quasi-drug only when the precedent of approval has been presented, however, this is not mentioned at all in the notification, etc. issued by the MHLW.


  • MHLW should shorten the review period for quasi-drugs for which review guidelines have been created and which are believed to be identical to already-approved quasi-drugs.
  • When submitting an application related to a quasi-drug that uses ingredients of the same standard as those contained in quasi-drugs already approved, re-examination of the pertinent contents mentioned in the separate sheet standard should be omitted in order to improve efficiency and shorten the review.
  • When ideas concerning the review change, this should not only be announced at the explanatory meeting for PMDA staff in charge but also be announced by issuing a notification or clerical communication after gaining understanding from the applicants through the collection of opinions, etc. using public comments in advance.