【Client Alert】Telepharmacy: Regulatory Evolution and Current Framework
Telepharmacy: Regulatory Evolution and Current Framework
This page provides an English executive summary of the Japanese article “オンライン服薬指導制度の変遷と現行制度の基本構造”. The full article is available in Japanese.
Key Questions (FAQ) / Summary
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Q1. What background led to the introduction of the telepharmacy system, and how was it initially operated?
ー With the advancement of community-based integrated care and changes in patients’ living environments, the demand for telepharmacy using tools such as video calls increased. In response, the system was institutionalized under the 2019 amendment to the Pharmaceuticals and Medical Devices Act (PMD Act) as an exception to the in-person requirement. However, at the initial stage, strict requirements—such as a prior history of in-person medication guidance and the obligation to prepare a medication guidance plan—limited its use. -
Q2. What are the differences between the COVID-19-related “0410 measure” and the current system?
ー The “0410 measure” introduced during the COVID-19 pandemic was a temporary and exceptional measure that allowed pharmacists, at their discretion, to provide medication guidance via telephone (audio only), including for first-time patients. This measure was abolished in April 2024. In contrast, under the current system (as of May 2026), telephone-only (audio-only) guidance is not permitted, and both audio and video are required. Moreover, the current system is not an extension of the exceptional measures but has been restructured as a permanent framework applicable in normal circumstances, balancing convenience and safety. -
Q3. How are prescriptions handled, and how are medications delivered when using telepharmacy?
ー Prescriptions can be handled based on prescription information sent from medical institutions to pharmacies via fax or email, allowing dispensing to proceed, with the original prescription being sent later. In addition to traditional paper prescriptions, an electronic prescription system has also been established, providing a safer and more efficient infrastructure for information sharing. Even when medication delivery services are used, it has been clarified that the pharmacy retains full responsibility for maintaining quality, ensuring delivery to the correct recipient, and confirming receipt. -
Q4. How has the scope of eligible medications expanded under the amended PMD Act effective May 2026?
ー Under the 2025 amendment to the PMD Act (effective May 2026), in addition to prescription drugs, “pharmacist-designated drugs” (yo-shido iyakuhin) have newly become eligible for sale through telepharmacy. These drugs, which are relatively new and have not yet undergone full risk assessment, were previously excluded from online sales and required in-person guidance. The scope has now been expanded to improve patient convenience. -
Q5. Are all pharmacist-designated drugs eligible for telepharmacy? Please explain the exceptions (Specified Pharmacist-Designated Drugs).
ー No, not all pharmacist-designated drugs are eligible for telepharmacy. Drugs designated by the Minister of Health, Labour and Welfare as requiring in-person sales or provision by a pharmacist for proper use are classified as “Specified Pharmacist-Designated Drugs” and must continue to be handled face-to-face. For example, as of May 20, 2026, emergency contraceptives (active ingredient: levonorgestrel) are designated as such. -
Q6. Can pharmacists provide telepharmacy services from outside the pharmacy?
ー Yes, it is possible under certain conditions. Following a regulatory review in September 2022, pharmacists may provide guidance from outside the pharmacy if requirements are met, such as obtaining the patient’s request and consent, ensuring that communication with the dispensing pharmacist is possible, and maintaining a level of patient privacy equivalent to in-person interactions. This has expanded the range of operational models available.
This English page is provided for informational purposes only. The Japanese version constitutes the authoritative text.
(執筆:Takuya Mima, Yosuke Aoki )

Counsel, Tokyo International Law Office
takuya.mima@tkilaw.com
Practice Areas: Life Sciences & Healthcare, Intellectual Property, M&A, Cross-border Transactions
Takuya Mima has more than a decade of experience at leading Japanese law firms, advising on a broad range of corporate matters, including mergers and acquisitions, strategic alliances, business reorganizations, and cross-border transactions.
He focuses particularly on the life sciences and healthcare sectors, where he regularly advises on intellectual property–related transactions such as licensing agreements, joint research and development arrangements, and brand and design protection. He also has substantial experience in intellectual property disputes, including patent litigation in the United States.
Takuya has further strengthened his practical insight through secondments to the legal department of a multinational pharmaceutical company and to the intellectual property division of a major manufacturing company. These experiences enable him to provide practical, business-oriented advice that bridges legal, regulatory, and intellectual property considerations.
He has also authored numerous publications on intellectual property and healthcare law.
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Associate, Tokyo International Law Office
yosuke.aoki@tkilaw.com