Key Facts
• August 29, 2025: Ministry of Health convened the “Pharmaceutical Affairs Council.”
• Approved emergency contraceptive “Levonorgestrel” (Aska Pharmaceutical) for OTC use.
• First designation as “Specific Guidance-Required Medicine” under revised pharmaceutical law.
• Levonorgestrel 1.5 mg tablet (NorLevo) repurposed for OTC sale.
• Sales restricted to pharmacists completing specialized training.
• Usage: Single tablet within 72 hours post-intercourse, consumed in pharmacist’s presence.
• No age restrictions based on global clinical trial data and safety reviews.
• Mandatory follow-up: Pregnancy test or medical consultation three weeks post-use.
• Sales conditions: Privacy measures, collaboration with local OB-GYNs, and pharmacist training.
• Parental consent not required to support young individuals avoiding unintended pregnancies.
• Additional measures for minors under 16 and suspected sexual abuse cases.
• Online pharmacist training opens September 19, 2025, via Japan Pharmacist Training Center.
• Post-approval monitoring: Three-year safety and usage survey required.
• Government to monitor OTC sales and ensure proper implementation of privacy and support measures.
Summary
On August 29, 2025, Japan’s Ministry of Health approved the emergency contraceptive Levonorgestrel (NorLevo, Aska Pharmaceutical) for over-the-counter (OTC) use, marking the first designation of a “Specific Guidance-Required Medicine” under the revised pharmaceutical law. The drug, to be sold only by pharmacists who complete specialized training, must be consumed within 72 hours post-intercourse in the pharmacist’s presence. No age restrictions apply, and parental consent is not required, ensuring accessibility for young individuals. Privacy measures, collaboration with local OB-GYNs, and follow-up protocols, including pregnancy tests or medical consultations three weeks post-use, are mandated. Additional safeguards are in place for minors under 16 and cases of suspected sexual abuse. Online training for pharmacists begins September 19, 2025, with post-approval monitoring to ensure safety and proper implementation. The government will oversee sales and provide support resources to ensure compliance and accessibility.
