Japan Panel Approves Over-teh-Counter Access too Emergency Contraceptive Pill
Tokyo, Japan - A panel advising Japan’s health ministry has recommended approval for Aska Pharmaceutical to sell its emergency contraceptive pill, Norlevo, without a prescription, marking a potential shift in access to “morning-after” pills in the country. The decision, reached at a meeting Friday, would make norlevo the first nonprescription emergency contraceptive available in Japan.
The panel stipulated that Norlevo be designated as a drug requiring consultation with a trained pharmacist before dispensing, to ensure safe usage. If the health ministry approves both the manufacturing and sales submission, and this designation, the pill could be available for purchase by year-end.
Notably, the panel opted against establishing a minimum age for access. However, pharmacists will be prepared to offer guidance to individuals under 16, Japan’s age of consent for sexual acts. Parental consent will no longer be a requirement for purchase. Details regarding specific sales methods are yet to be determined and will be discussed at a future date.
This move is facilitated by revisions to Japan’s pharmaceuticals and medical devices law, enacted in May, which created a new category for drugs necessitating face-to-face pharmacist instruction. Norlevo is anticipated to be the first medication classified under this new regulation.
currently, obtaining emergency contraception in Japan requires a doctor’s examination and a prescription. The Ministry of Health, Labor and Welfare began conducting trial sales of emergency contraceptive pills without prescriptions for those aged 16 and older in 2023, following a report in May of the same year from a group of experts outlining potential challenges with over-the-counter availability.
According to Aska Pharmaceutical, Norlevo is effective in preventing unwanted pregnancies when taken orally within 72 hours of unprotected sexual intercourse.The company submitted its application for nonprescription sales in June 2023.
