Japan's health ministry has drafted an amendment that would place a women's 5% minoxidil hair product on the list of pharmacist-guidance-required drugs. The Pharmaceutical Evaluation Division of the ministry's Pharmaceutical Affairs Bureau opened public comment on October 8.
What the draft covers
The entry is narrow. It adds minoxidil in a women's hair-growth preparation containing 5.0g of minoxidil per 100mL, limited to products aimed at people aged 20 and over. It goes into item 1 of the existing designation notice.
Under the law, a drug in this category has a mild effect on the body, is meant to be chosen by consumers on the basis of information from a pharmacist, and needs face-to-face information from a pharmacist for proper use. The health minister designates such drugs after hearing the pharmaceutical affairs council. The draft follows a discussion at the council's subcommittee on guidance-required and over-the-counter drugs on October 2.
Why this product qualifies
The draft's own explanation is that minoxidil preparations are approved as over-the-counter drugs, but none has been approved as a drug containing 5% minoxidil for women aged 20 and over. That puts it in the item 1 category of drugs with an approved active ingredient but a different route, indication, dosage form or dose, still within the re-examination period.
The designation is not a marketing approval. The draft does not name a product or a company.
Timetable
The notice sets the comment period from October 8 to Friday, November 6, with comments required to arrive by then. The e-Gov case page lists the cut-off as 0:00 on November 7, which is the end of November 6. Comments go through e-Gov, by email or by post, in Japanese only. The ministry says it will not reply to individual comments.
The planned notification date is April 2027, and the draft sets the application date as the notification date.