JAPAN Trends and Developments Contributed by: Satoshi Ogawa, Yuto Noro, Hitoshi Fujimaki and Yuka Hirata, TMI Associates
The Guidelines also permit telesurgery under specific conditions, allowing skilled surgeons to operate remotely with the on-site physicians, using advanced communication technologies. Such procedures must adhere to detailed pro- tocols established by relevant medical asso- ciations, which define applicable diseases and patient conditions. Online medication guidance In Japan, the separation of prescribing and dis- pensing practices mandates that physicians prescribe drugs, while pharmacists dispense them. Before the 2020 Amendment to the Act on Securing the Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medi- cal Devices (the “PMD Act”), pharmacists were required to provide face-to-face guidance when dispensing prescription drugs. The 2020 Amendment introduced online medi- cation guidance, permitting pharmacists to offer consultations via video and audio; however, voice-only (telephone) consultations remain prohibited. Further deregulation occurred in 2025. On 12 February 2025, a proposed amendment to the PMD Act was approved, which will allow over- the-counter (OTC) drugs to be sold even at loca- tions such as convenience stores without an on- site pharmacist, provided that consumers first receive online consultation from a pharmacist. To ensure safety, the pharmacy providing the online consultation and the retail outlet must be located within the same prefecture. This initiative aims to enhance consumer convenience while maintaining appropriate safety measures. Additionally, by the end of fiscal year 2025, dis- cussions are expected to take place regarding the potential sale of designated prescription
drugs with online medication guidance based on the pharmacist’s discretion. Example of a telemedicine system Recently, the number of companies offering telemedicine systems has increased in Japan. For example, Medley Inc provides the “Clinics Telemedicine System”, which is a popular tel- emedicine system in the Japanese medical plat- form sector. One of its apps allows for online appointments, video chat examinations, medi- cation guidance, etc, thereby allowing patients to continue receiving treatment without leaving their homes. LINE Healthcare Corporation also provides a telemedicine system called “LINE Doctor”, which enables users to schedule medi- cal appointments, engage in free video calls, and make payments using LINE, the most popular messaging app in Japan. Increase in healthcare-related apps Background In 2020, a therapeutic app made by Cure App, Inc. became the first Software as a Medical Device (SaMD) approved in Japan. This app is designed to help nicotine-dependent patients stop smoking, and is covered by health insur- ance. Since then, the number of applications for pharmaceutical approval of therapeutic apps has been increasing. Moreover, although there is a functional overlap with therapeutic apps, the development of recording apps, which are provided as a preparatory stage for the develop- ment of therapeutic apps, is rapidly increasing as licences and approvals are not required under the PMD Act. Therapeutic apps and symptom-recording apps Therapeutic apps are used for the “treatment” of a specific disease in a medical setting and may be circumscribed as follows:
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