Japan has for the first time approved over-the-counter sales of an emergency contraceptive pill, its manufacturer says, allowing women in the country to take the medication without prescription.
ASKA Pharmaceutical said wider access to the pill would “empower Japanese women in the area of reproductive health”. A date for it to go on sale has yet to be announced.
The pill will be labelled as “medicine requiring guidance”, meaning women must take it in the presence of a pharmacist.
The “morning-after” pill – a form of emergency contraception – is already available without prescription in more than 90 countries, and is designed to prevent an unwanted pregnancy.
It works by stopping a woman’s egg from fully developing or attaching to the wall of the uterus. It usually has to be taken within three to five days of having 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 the role of women, mean it has been slow to approve drugs related to women’s reproductive health.
ASKA Pharmaceutical said in a statement on Monday that it “has obtained the marketing authorisation as a switch to OTC [over-the-counter] use of the emergency contraceptive pill commercialised under the trademark Norlevo”.
There will be no age restrictions on buyers and no requirement for parental consent, the daily newspaper Mainichi Shimbun reported.
The company said it had filed for regulatory approval in 2024, following prescription-free trial sales of the pill the year before.
During the trial, Norlevo was made available at 145 pharmacies in Japan. Until then, the pill had only been supplied at clinics or pharmacies with a doctor’s examination and prescription.
At the time, rights groups criticised the trial, saying it was too small, and called for restrictions to be lifted. Campaigners have long argued that requiring a prescription deterred younger women and rape victims from accessing emergency contraception.
Selling the drug without prescription was first discussed by a health ministry panel in 2017 – the public consultation found overwhelming support across the country.
But officials stopped short of giving it the green light then, saying that making it more easily available would encourage irresponsible use of the “morning-after” pill.
Norlevo – and the generic version levonorgestrel – works best within 72 hours after unprotected sex and has an efficacy rate of 80%.
