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Japan Approves First Over-the-Counter Morning-After Pill

Regulators shift to a pharmacist-supervised access model following years of debate.

Overview

  • ASKA Pharmaceutical said it obtained manufacturing and marketing approval to sell Norlevo without a prescription.
  • The pill is classified as a “medicine requiring guidance,” requiring women to take it in the presence of a pharmacist.
  • Reporting indicates there will be no age restrictions and no requirement for parental consent for purchase.
  • The decision follows discussions dating to 2017 and a 2023 pilot at 145 pharmacies with trial prices of 7,000 to 9,000 yen.
  • Emergency contraception works best within 72 hours of sex, and similar pills are available over the counter in more than 90 countries, consistent with WHO guidance.