OTC (Over the Counter) drugs include common cold remedies, digestive aids, and eye drops that are considered safe for self-use. Among these, drugs that were originally prescription-only but have been reclassified for general sale after their safety and efficacy were confirmed are referred to as “switch OTC” medicines. Typical examples in Japan include Loxonin S (analgesic), Allegra FX (antihistamine), and Gaster 10 (acid reducer), all of which were once available only through medical institutions. In recent years, more potent drugs, such as certain gastric medicines and emergency contraceptives, have also been made available through this system, expanding consumers’ access to treatment options. These developments are expected to empower citizens to take greater responsibility for their own health management while also helping to reduce the financial burden on Japan’s public health insurance system.when the safety, efficacy, dosage, and administration of a switch OTC are identical to the prescription version. Moreover, as of August 2024, safety monitoring can now be conducted digitally by attaching QR codes to products and collecting feedback from purchasers online reducing the burden on pharmaceutical companies while maintaining pharmacovigilance standards. Sales regulations have also been refined. Switch OTC medicines must be sold face-to-face by pharmacists for the first three years after their reclassification, after which online sales become permitted. In May 2025, an amendment to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices was promulgated, introducing a new category that allows continued face-to-face sales for drugs requiring particularly careful instruction, such as emergency contraceptives. This amendment strengthened both consumer safety and sales flexibility, paving the way for further expansion of the switch OTC framework. Additionally, Japan introduced the Self-Medication Tax Incentive in 2017 to financially encourage individuals to purchase switch OTC medicines. Japan has been facing a continuous rise in medical To promote self-medication, Japan has gradually Previously, candidate substances for switching were Since this change, the number of approved OTC expenditures, which has made the efficient use of healthcare resources a pressing issue. According to OECD data (2023), the average number of annual outpatient consultations per person in Japan is approximately eleven times, the second highest among OECD member countries after South Korea. While this reflects Japan’s excellent accessibility to healthcare services, it also indicates a tendency for individuals to visit medical institutions even for minor ailments. In this context, promoting self-medication, where people manage mild symptoms on their own, has become an important policy objective to alleviate the burden on medical institutions and to contain healthcare costs.Supporting this initiative is the availability of over-the-counter (OTC) medicines, which can be purchased at pharmacies and drugstores without a doctor’s prescription. developed a structured approval system for switch OTC drugs.selected primarily by the Pharmaceutical Society of Japan, in consultation with relevant medical associations, which collectively determined approval eligibility. However, following a major institutional reform in 2016, the process was overhauled: requests for switching are now collected broadly from consumers, academic societies, and industry organizations, and are reviewed by the Evaluation and Discussion Committee within the Ministry of Health, Labor, and Welfare (MHLW). This reform improved transparency and predictability for pharmaceutical companies seeking to transfer prescription drugs to OTC status.ingredients switches has remained between zero and four per year, reflecting a cautious evaluation process. To streamline this system, the government has also simplified application procedures and clarified post-approval sales rules. For instance, under the October 2024 reform, companies are no longer required to submit new clinical trial data Daiki WakabayashiDevelopment and Challenges of the OTC Switch Policy in JapanJohann Wolfgang Goethe-Universit, Germany7OTC Switch and Self-Medication Policy
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