Japan’s Regulatory Framework for Online Medical Care and Telepharmacy

Executive Summary & Key Takeaways (Click to expand)

Japan’s Regulatory Framework for Online Medical Care and Telepharmacy

Telemedicine has recently attracted increasing attention in Japan. With key legislative amendments taking effect in April and May 2026, Japan has established an updated statutory framework for online medical care and expanded the operational scope of telepharmacy. This executive summary provides a high-level briefing on these regulatory developments for life science and healthcare providers, platform operators, and overseas businesses exploring opportunities in Japan.

• Online Medical Care Framework: Governed by the Medical Care Act and 2026 reforms (effective 1 April 2026), online medical care strictly requires real-time simultaneous audio and video communication. The reforms clarified the legal framework for online medical care, drawing on the key principles set out in the pre-existing MHLW guidelines, regulating provider qualifications, initial consultation safeguards, and mandatory institutional notifications.
• Online Medical Care Access Facilities: The 2026 reforms established a new statutory category of facility where patients facing digital, equipment, or geographical barriers can receive remote medical care. Operators of these facilities must file local notifications, ensure physical privacy and cybersecurity, and adhere to strict advertising restrictions.
• Telepharmacy Expansion: Governed by the PMD Act, telepharmacy allows licensed pharmacists to provide medication guidance online. Amendments effective 1 May 2026 expanded telepharmacy beyond prescription drugs to include Pharmaceuticals Requiring Guidance (要指導医薬品), excluding only MHLW-designated high-risk items (e.g., emergency contraceptives containing levonorgestrel).
• Cross-Border Considerations: Japanese medical laws apply where a physician located in Japan provides remote care to a patient located overseas. However, providers should also assess the potential application of the laws of the country or region in which the patient is located, including local healthcare and medical licensing laws, drug export, import and distribution regulations, and cross-border personal data transfer requirements on a country-by-country basis.

KEY TAKEAWAYS

1. Strict audio-visual mandate: Both online medical care and telepharmacy strictly require real-time, simultaneous audio and video; voice-only or text-based consultations do not qualify under Japanese law.
2. Creation of Access Facilities: The new "Online Medical Care Access Facility" framework allows commercial operators to establish dedicated remote consultation spaces, bridging the digital divide under regulatory oversight.
3. Expanded scope for telepharmacy: The May 2026 PMD Act reforms permit telepharmacy for Pharmaceuticals Requiring Guidance (要指導医薬品), creating broader market opportunities for digital pharmacy platforms.
4. In-person safeguards preserved: Initial online consultations generally require pre-consultation screenings, and designated high-risk drugs (such as emergency contraceptives) remain restricted to in-person pharmacy visits.
5. Dual regulatory exposure overseas: Cross-border telemedicine from Japan requires consideration of not only Japanese medical laws but also the healthcare laws, pharmaceutical regulations, licensing, and data privacy laws of the country or region in which the patient is located.

Telemedicine has recently attracted increasing attention in Japan. A series of amendments to the relevant Japanese healthcare laws and regulations has been introduced, while an increasing number of overseas businesses are exploring potential opportunities in this area. This article provides an overview of Japan’s regulatory framework for telehealth services, with a particular focus on online medical care and online medication counselling / telepharmacy (referred to in this article as “telepharmacy”), including the latest key amendments to the relevant Japanese healthcare laws and regulations, which took effect in April and May 2026. This article is based on information available as at the date of this article.

1. Online Medical Care in Japan

OVERVIEW

Q1 Is online medical care allowed in Japan? If so, how is it defined?

-Online medical care is allowed in Japan, subject to the requirements of the Medical Care Act and its subordinate legislation. The Medical Care Act and related subordinate legislation were amended, with the relevant amendments taking effective on 1 April 2026, to establish a statutory framework for online medical care. These reforms largely codified the existing regulatory framework under the Japanese-language guidelines provided by the Ministry of Health, Labour and Welfare (“MHLW”) entitled “Guidelines for the Proper Implementation of Online Medical Treatment” (the “Online Medical Care Guidelines”, which term refers to those guidelines as in effect at the relevant time) and were intended to promote the appropriate provision of online medical care in Japan (collectively, the “2026 Online Medical Care Reforms”).
Under the Medical Care Act, online medical care is defined as medical or dental care provided through a telecommunications system that enables a physician or dentist and a remotely located patient to communicate in real time using audio and video (both of which are required), while allowing each to perceive the other’s condition.

Q2 Please provide a high-level overview of the legal framework regarding online medical care in Japan.

-Among other applicable requirements, online medical care must be provided in accordance with the Standards for the Appropriate Provision of Online Medical Care, a set of legally binding requirements set out in Article 9-6-2 et seq. of the Enforcement Regulations on the Medical Care Act (the “Online Medical Care Standards”), which are available only in Japanese. For more details on the Medical Care Standards, please refer to Q3 through Q6 below.

The 2026 Online Medical Care Reforms also introduced a new statutory category of location at which patients can receive online medical care. In addition to patients’ homes and other locations that may qualify on a case-by-case basis, such as workplaces and schools, patients may now receive online medical care at an “Online Medical Care Access Facility”. This new category was introduced to improve access to online medical care, particularly for patients who have difficulty receiving it at home due to limited digital literacy, inadequate equipment or connectivity, or geographical constraints. It is defined as a facility that an operator, in the course of business, makes available to hospitals and certain other medical facilities (i.e., physicians or dentists working thereat) as a place where patients may receive online medical care provided by those physicians or dentists.For more details on establishing and operating an Online Medical Care Access Facility, please refer to Q6 below.

REQUIREMENTS APPLICABLE TO HEALTHCARE PROFESSIONALS AND INSTITUTIONS

Q3 Who may provide online medical care in Japan? Are other healthcare professionals authorised to provide it under the applicable rules (e.g., nurses, psychologists, dietitians or alternative healthcare practitioners)?

-Only physicians and dentists licensed by the MHLW under the applicable Japanese professional licensing laws may independently provide online medical care in Japan.

Other healthcare professionals are not authorised to provide online medical care independently. However, a physician may have any of the following healthcare professionals assist with the provision of online medical care: public health nurses, midwives, registered nurses, assistant nurses, physical therapists, occupational therapists, and speech-language-hearing therapists. A dentist may likewise be assisted by a dental hygienist. Among other requirements, such assistance is permitted only if:

• the assistance is provided in accordance with a treatment plan, written home-visit nursing instructions, or another document setting out the physician’s or dentist’s instructions;
• the assistance remains within the scope reasonably anticipated in such instructions;
• the healthcare professional performs only those activities that they are legally authorised to perform under the laws governing their profession; and
• where another physician, dentist or other healthcare professional is present during the online medical care, the physician or dentist explains such person’s presence to the patient and obtains the patient’s consent on each occasion.

Where the arrangement involves a public health nurse, midwife, registered nurse or assistant nurse, the MHLW’s Online Medical Care Guidelines refer to this model as “D to P with N” and, in describing this model, contemplate that such healthcare professional will be physically present with the patient during the online medical care.

Q4 Must online medical care be provided in combination with in-person medical care? Can it be provided from a patient’s initial consultation with a physician or dentist?

-The MHLW explains on its website that, as a general principle, online medical care should be appropriately combined with in-person medical care. In addition, the MHLW’s Online Medical Care Guidelines provide that an initial online consultation should, in principle, be conducted by a patient’s regular physician—a physician who provides ongoing care to the patient and is familiar with the patient’s medical history, current health condition, and treatment needs. An initial consultation may nevertheless be conducted online by another physician or dentist, subject to the safeguards described below.

These principles reflect the fact that physicians and dentists generally have access to less clinical information during an online consultation than during an in-person consultation. Accordingly, the Online Medical Care Standards require physicians and dentists to:

• explain the key features, benefits and potential disadvantages of online medical care and obtain the patient’s agreement to proceed;
• determine whether online medical care is medically appropriate and, if not, take appropriate steps to transition the patient to in-person medical care, and maintain the arrangements necessary to enable such transition;
• where a physician or dentist who does not already have sufficient medical information about the patient proposes to conduct the patient’s initial consultation online, first conduct a real-time audio-visual pre-consultation to determine whether proceeding with online medical care is appropriate; and
• comply with restrictions on prescribing certain medications during an initial consultation or where the relevant symptoms have not previously been assessed in person.

Q5 Are there any other specific requirements applicable to physicians, dentists, hospitals or clinics that provide online medical care services?

-Yes. No separate authorisation is required solely for the provision of online medical care by an existing hospital or clinic. However, in addition to the requirements described above, the following key obligations apply.
Physicians and dentists must:

• prepare and retain a treatment plan for providing online medical care, generally based on a prior in-person medical assessment;
• verify the patient’s identity, identify themselves to the patient and enable the patient to verify their professional qualifications; and
• be affiliated with a hospital or clinic, disclose that institution and its contact details, and provide online medical care from an appropriate and private environment in which the necessary information concerning the patient can be accessed.

Hospital or clinic operators and managers must:

• notify the competent local authority that physicians or dentists working at the institution provide online medical care, and notify it of any subsequent changes to that information;
• provide the physicians and dentists concerned with the guidance and other measures necessary for them to acquire the knowledge and skills required to provide online medical care;
• where online medical care is provided to a patient at an Online Medical Care Access Facility, verify that the facility satisfies the applicable privacy and information-security requirements and discontinue the online consultation or take other appropriate action if its compliance cannot be confirmed.

Q6 Are there specific requirements applicable to operators of Online Medical Care Access Facilities?

-Yes. The principal requirements applicable to the operator of an Online Medical Care Access Facility include the following:

• The operator must file a notification with the competent local authority within 10 days after establishing the facility. Notifications are also required following changes to the notified information.
• The operator must take measures to ensure that the facility is clean and safe, provides a physically separated environment that protects patient privacy, and maintains appropriate information security for the systems used for online medical care. A corporate operator must also appoint a person responsible for the management and operation of the facility.
• Advertising concerning the facility is subject to stringent restrictions.

2. Telepharmacy in Japan

OVERVIEW

Q7 Is telepharmacy allowed in Japan? If so, how is it defined?

-Telepharmacy is allowed in Japan, subject to the requirements of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the “PMD Act”) and its subordinate legislation.
Under the PMD Act and its subordinate legislation, telepharmacy is defined as the provision by a pharmacist of information and pharmaceutical guidance necessary to ensure the appropriate use of medication through a telecommunications system that enables the pharmacist and a remotely located patient to communicate in real time using audio and video (both of which are required), while allowing each to perceive the other’s condition.

Q8 Please provide a high-level overview of the legal framework regarding telepharmacy in Japan.

-Under the PMD Act, medicines are broadly divided into three categories: (i) medicines requiring dispense by a pharmacist (the “Pharmacy-only Pharmaceutical” / 薬局医薬品), (ii) non-prescription medicines that require individual information and pharmaceutical counselling from a pharmacist before sale, typically because they have only recently been switched from prescription status or otherwise present characteristics requiring a higher level of pharmacist involvement than ordinary OTC medicines (the “Pharmaceuticals Requiring Guidance” / 要指導医薬品), and (iii) non-prescription medicines intended to be selected and used by consumers, typically for minor health conditions or health maintenance, on the basis of information provided by pharmacists or other qualified healthcare professionals (the “OTC Pharmaceutical” / 一般用医薬品).
In general, the sale or supply of Pharmacy-only Pharmaceuticals and Pharmaceuticals Requiring Guidance requires a pharmacist to provide the purchaser or patient with individual information and pharmaceutical guidance. Telepharmacy was introduced as a means of providing such guidance and was previously available only in respect of medication dispensed pursuant to a prescription, which represents only a subset of the Pharmacy-only Pharmaceuticals in category (i).
This limitation was relaxed under reforms that took effect on 1 May 2026. Pharmaceuticals Requiring Guidance (category (ii)) may now also be sold or supplied following telepharmacy, under amendments to the PMD Act and related subordinate legislation that took effect on that date (such amendments, collectively, the “2026 PMD Act Reforms”). However, certain Pharmaceuticals Requiring Guidance designated by the MHLW must be sold or supplied in person by a pharmacist and are not eligible for telepharmacy (such designated medicines, the “Specified Pharmaceuticals Requiring Guidance” / 特定要指導医薬品). As at 20 May 2026, emergency contraceptives containing levonorgestrel were the only medicine designated as Specified Pharmaceuticals Requiring Guidance.

REQUIREMENTS APPLICABLE TO HEALTHCARE PROFESSIONALS AND INSTITUTIONS

Q9 Who can practise telepharmacy in Japan? Please indicate whether other healthcare professionals are authorised to provide it under the applicable rules.

-Only pharmacists licensed by the MHLW under the Pharmacists Act may provide telepharmacy in Japan. Other healthcare professionals are not authorised to provide telepharmacy independently.

Q10 Are there specific requirements applicable to pharmacists or pharmacy operators that provide telepharmacy services?

-Yes. Under the PMD Act and its subordinate legislation, in addition to the general requirements applicable to both in-person and telepharmacy, the following key requirements apply specifically to telepharmacy:

• telepharmacy must be provided at the patient’s request and on a case-by-case basis;
• pharmacists must confirm whether there are any circumstances that would make it difficult to provide the counselling online and determine, on their own responsibility, whether it can be appropriately provided online;
• pharmacists must inform the patient, before proceeding with telepharmacy, of (i) the matters that would affect the feasibility of proceeding with telepharmacy, such as the patient’s level of understanding of the medication where medication involving complex administration procedures is to be supplied for the first time, and the potential impact of any disruption to the internet connection, and (ii) the risks associated with telepharmacy, such as information-security concerns; and
• telepharmacy may be provided from the pharmacy or, subject to certain conditions, from another location at which the pharmacist providing the counselling can communicate with a pharmacist dispensing the medication at the pharmacy.

In addition, the MHLW’s notice dated 30 September 2022 entitled “Implementation Guidelines for Telepharmacy”, which are available only in Japanese, should also be consulted. Among other matters, the Guidelines require pharmacy operators and pharmacists to take appropriate measures to ensure that medicines supplied following telepharmacy is appropriately delivered to the patient.

3. Cross-border Online Medical Care

Q11 Can patients residing outside Japan to receive online medical care from physicians in Japan?

-According to the MHLW’s Q&A on the Online Medical Care Guidelines, published in April 2026 and available only in Japanese, if a physician at a Japanese medical institution provides online medical care to a patient located outside Japan, the relevant Japanese medical laws, including the Medical Care Act, and the Online Medical Care Guidelines apply because the physician’s medical activities, including examination, diagnosis and prescription, are performed in Japan. The physician must also comply with the healthcare laws and regulations of the country in which the patient is located. Accordingly, the permissibility of cross-border online medical care must be assessed separately for each jurisdiction in which the relevant patients are located.
Various other laws and regulations may also need to be considered. These include the rules governing the export of medicines where medicines are shipped from Japan to a patient in another country, as well as the rules applicable to cross-border transfers of personal information.

（Written by：Takuya Mima,Yuki Kimura）

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