Japan has for the first time allowed the over-the-counter sale of an emergency contraceptive pill, its manufacturer said, allowing women in the country to take the drug without a prescription.
ASKA Pharmaceutical said wider access to the pill would “empower Japanese women in the field of reproductive health.” The date it goes on sale has not yet been announced.
The pill will be labeled as a “medication requiring supervision,” meaning women must take it in the presence of a pharmacist.
The morning-after pill, a form of emergency contraception, is already available without a prescription in more than 90 countries and is designed to prevent unwanted pregnancy.
It works by preventing a woman’s egg from fully developing or attaching to the wall of the uterus. It should generally be taken within three to five days of unprotected sex, but the sooner it is taken, the more effective it is.
Japan’s conservative views, rooted in patriarchy and deeply traditional views on women’s roles, mean that Japan has been slow to approve drugs related to women’s reproductive health.
ASKA Pharmaceutical said in a statement Monday that it had “obtained marketing authorization to move to OTC.” [over-the-counter] use of the emergency contraceptive pill marketed under the brand name Norlevo.
There will be no age limit for buyers and no requirement for parental consent, the Mainichi Shimbun daily reported.
The company said it had filed for regulatory approval in 2024, following non-prescription trial sales of the pill the previous year.
During the trial, Norlevo was made available in 145 pharmacies in Japan. Until then, the pill was only provided in clinics or pharmacies on medical advice and on prescription.
At the time, rights groups criticized the trial as too restricted and called for the restrictions to be lifted. Activists have long argued that requiring a prescription deters young women and rape victims from accessing emergency contraception.
Selling the drug without a prescription was first discussed by a Department of Health panel in 2017 – the public consultation found overwhelming support across the country.
But authorities did not give the green light at that time, saying that making it more readily available would encourage irresponsible use of the morning-after pill.
Norlevo – and the generic version of levonorgestrel – work best within 72 hours of unprotected sex and have an 80% effectiveness rate.
