Pharmaceutical Advertising 2026 Comparisons

The advertising of medicines in Japan is regulated by both Japanese laws and regulations, as well as by self‑regulatory codes created by pharmaceutical industry trade associations. The primary law governing pharmaceutical advertising is the Pharmaceuticals and Medical Devices Act (Act No 145 of 10 August 1960, as amended) (the “PMD Act”). Major self‑regulatory codes include those issued by the Japan Pharmaceutical Manufacturers Association (JPMA) and the Japan Self‑Medication Industry (JSMI).

Laws and Regulations

In Japan, the Act against Unjustifiable Premiums and Misleading Representations (Act No 134 of 15 May 1962, as amended) (UPMRA) sets out general rules concerning advertising. However, for pharmaceutical advertising, the PMD Act – Japan’s main law regulating drugs – contains several special provisions that apply specifically to such advertisements.

PMD Act

Articles 66, 67 and 68 of the PMD Act provide for the following.

The prohibition of advertisements for unauthorised drugs

The PMD Act states that no person shall advertise the name, manufacturing process, indications or performance of a drug before obtaining the required marketing authorisation from the Japanese government.

The prohibition of false or exaggerated advertisements

The PMD Act prohibits any explicit or implicit advertisement, description or dissemination of information about a drug that uses false or exaggerated statements regarding its name, manufacturing process, indications or performance.

The prohibition of advertisements endorsed by a doctor

The PMD Act bans advertisements that create a false impression that a medical doctor or other healthcare professional endorses the efficacy or performance of a drug.

The prohibition of obscene documents or images

The PMD Act prohibits the use of obscene documents or images, or those suggesting illegal abortions in connection with drug advertising.

The regulation of advertisements for drugs for designated diseases

The PMD Act prohibits the advertising to the general public of drugs intended for the treatment of cancer, sarcoma or leukaemia when such products are likely to be highly dangerous if used without physician or dentist supervision.

Administrative fines

The PMD Act includes provisions for administrative fines for violations of rules regarding false or exaggerated advertising, as well as cease‑and‑desist orders requiring pharmaceutical companies to correct improper advertisements.

The MHLW Regulations

The Ministry of Health, Labour and Welfare (MHLW) – the authority responsible for regulating medicines in Japan – has issued several regulations and notices to enforce the PMD Act, including the PMD Act Enforcement Ordinance, the PMD Act Enforcement Regulations and other official notices.

One key document is the “Standards for Appropriate Advertising concerning Medical Goods” (Notification No 0929‑4 of the Pharmaceutical Safety and Environmental Health Bureau, dated 29 September 2017) (the “MHLW Standards”). These standards serve as the central regulatory framework for pharmaceutical advertising.

The MHLW Standards

The MHLW Standards establish the rules that all individuals and entities must follow when advertising drugs.

Section 4 consists of two parts.

Part One (Articles 1–3 of Section 4): Interpretation of “False or Exaggerated Advertisements” under Article 66(1) of the PMD Act

This section sets out rules concerning:

• expressions related to product names;
• expressions related to manufacturing processes; and
• expressions related to indications, dosage, administration and safety.

Part Two (Articles 4–14 of Section 4): Rules to Prevent Misuse, Drug Abuse and the Deterioration of Drug Reliability

This section prescribes rules and restrictions regarding:

• the inducement of excessive use or abuse of drugs;
• advertising prescription‑only medicines;
• expressions related to drug performance in advertising to the general public;
• drug addictiveness warnings;
• precautions;
• slander of other companies’ products;
• endorsements by healthcare professionals;
• premium advertising;
• offensive advertising;
• email advertising;
• statements made on television or radio programmes; and
• the use of drugs as cosmetics or food.

The Detailing Guidelines

To prevent the dissemination of inappropriate information during promotional activities, the MHLW issued the “Guidelines Concerning Detailing Activities of Ethical Drugs” (the “Detailing Guidelines”). These guidelines cover:

• basic principles for detailing activities;
• company management responsibilities, including organisational measures such as establishing independent supervisory divisions, staff training and record‑keeping;
• responsibilities of individuals who engage in detailing activities; and
• guidelines for providing information on unauthorised drugs and off‑label uses.

Self‑Regulatory Codes

With regard to prescription-only medicines, a trade association of leading Japanese pharmaceutical research companies issues the major self-regulatory codes. In particular, the JPMA Code is the main regulatory code that regulates pharmaceutical advertisements. The JPMA Code has two chapters. The first chapter is the Code of Practice (the “JPMA Code of Practice”) and the second chapter is the Promotion Code (the “JPMA Promotion Code”). The JPMA Code establishes the rules that all member companies must comply with when promoting prescription-only medicines.

The JPMA has also issued several additional guidelines relating to pharmaceutical promotion. Among these are the Guidelines for the Drafting of Prescription Pharmaceutical Products’ Informational Material (the “JPMA Drafting Guidelines”) (see 5. Advertising to Healthcare Professionals).

With regard to advertising over-the-counter (OTC) medicines, the JSMI, a trade association of Japanese over-the-counter manufacturers, issued the Guidelines for Proper Advertising of Over-the-Counter Medicines (the “OTC Guidelines”). The OTC Guidelines apply to the advertising of non-prescription drugs to the general public. In particular, the OTC Guidelines regulate advertising through newspapers, magazines, television, radio, websites and other forms of mainstream media to ensure the appropriateness of publicity and advertising activities of non-prescription drugs.

Self‑regulatory codes apply only to the member companies of the specific trade association that created the code. For example, the codes established by the JPMA apply exclusively to pharmaceutical companies that are members of the JPMA.

Conduct that violates self‑regulatory codes does not necessarily violate Japanese laws or regulations; such conduct is illegal only if it independently breaches Japanese laws or regulations. However, a company that violates these self‑regulatory codes may still face sanctions under the codes, which can potentially harm its reputation.

There have been no important updates in the past year and the authors do not anticipate any in the near future.

Notice No 148 dated 29 September 1998, issued by the Pharmaceutical Safety Bureau of the MHLW, defines “advertising” for the purposes of the PMD Act. This notice states that “advertising” has all of the following three characteristics:

• it has a clear intention to induce customers to make purchases;
• the product names of particular medicines are clearly expressed; and
• it can be seen by the general public.

Advertising and other information are distinguished by the definition of “advertising” given in 2.1 Definition of Advertising. First, advertising must be clearly intended to induce customers to make purchases. For example, a book in a medical library describing certain drugs and aimed at researchers is unlikely to have such an intention.

The second requirement – the clear expression of product names – may be met even when specific product names are not mentioned. This can occur if the general public would be able to recognise particular medicines from the pictures or descriptions used in the advertisement.

Finally, the third requirement – the ability to be seen by the general public – would generally not be satisfied if the relevant information is provided only to patients in a hospital, as the narrow scope of distribution limits the potential for the information to reach the general public.

Disease‑awareness campaigns and other patient‑facing information do not qualify as “advertising” under the PMD Act unless they satisfy all three parts of the definition above. For example, a disease‑awareness campaign that informs the public in a general way about a disease and does not name specific medicines is not considered “advertising” under the PMD Act. However, a disease‑awareness campaign that provides patient‑facing information about prescription‑only medicines to the general public risks being considered “advertising” under the PMD Act.

In this regard, the JPMA Code of Practice recommends that the content of disease‑awareness activities targeting ordinary citizens and patients be carefully examined during the planning stages to ensure that they will not be considered prohibited advertising.

Press releases regarding medicines are not prohibited. However, if a press release satisfies the three parts of the definition of advertising mentioned in 2.1 Definition of Advertising, both the regulations concerning advertising under the PMD Act and the MHLW Standards will apply.

Generally, the restrictions under the PMD Act are more stringent when the target audience is the general public than when the target audience is healthcare professionals. For example, advertisements for pharmaceutical products used for cancer, sarcoma or leukaemia aimed at the general public are prohibited under Article 67 of the PMD Act.

Comparative advertising of medicines is not prohibited but is restricted by Japanese law and self‑regulatory codes. According to the Commentary to Section 4, Article 9 of the MHLW Standards, a pharmaceutical company’s comparative advertising must only feature its own products, and the advertising must specify the names of those products. Comparisons with competitors’ products are prohibited. In addition, when a pharmaceutical company compares two of its own products, the company must ensure that it provides a sufficient explanation of the products.

Further, the Consumer Affairs Agency has issued general guidelines for comparative advertising. These guidelines suggest that a comparative advertisement may be considered a “Misleading Representation” prohibited under the UPMRA if:

• it makes comparisons using unproven or unprovable facts;
• it emphasises unimportant matters as if they were important, or makes comparisons based on an unfair selection of products; or
• it merely slanders or defames competitors’ products.

Article 68 of the PMD Act expressly prohibits advertising unauthorised medicines or unauthorised indications. However, providing information on unauthorised medicines or unauthorised indications is permitted when the information does not fall within the definition of “advertising” under the PMD Act.

Guidelines for Providing Information

The Detailing Guidelines allow the provision of information on unauthorised medicines and unauthorised indications only when (i) the information is requested by healthcare professionals, patients, patient organisations, and/or the general public, and (ii) all of the following conditions are met:

• information on unauthorised medicines and unauthorised indications must be separated from other promotional activities;
• information may only be provided to individuals who have actually requested it;
• information must be accurate and based on scientific and objective evidence, without omissions, exaggerations, emphasised points, or misleading summaries;
• information relating to a clinical trial involving a pharmaceutical company may be provided only if the research complies with Good Clinical Practice, the Clinical Trials Act, or other equivalent rules;
• negative information, such as information on adverse effects, may be provided;
• it must be clearly indicated that the relevant indication, dosage, or method of administration has not been approved; and
• records must be prepared and maintained detailing the information that has been provided on unauthorised medicines and unauthorised indications.

Cases Permitting Additional Information

The JPMA Promotion Code requires member companies to provide only certain information – such as indication, dosage, and administration – that does not deviate from the approved label for the relevant drug. However, the Commentary to the JPMA Promotion Code lists several situations in which additional information may be provided, so long as the purpose is to promote the right to know about scientific and medical advancements for medical and pharmaceutical professionals as well as the general public. These situations include:

• presenting research findings at scientific conferences or in scientific journals;
• displaying exhibition materials at an international scientific conference (limited to unapproved drugs that have been approved in at least one country);
• supplying previously reviewed academic literature; and
• disclosing information to stockholders as required by law.

Moreover, the Commentary notes that, even when these activities are permitted, companies must take special care to avoid engaging in any inappropriate promotional activities for their own commercial purposes.

The Commentary to the JPMA Promotion Code identifies two situations in which providing information on unauthorised medicines or unauthorised indications during a scientific conference aimed at healthcare professionals is permitted.

The first situation is the presentation of clinical research results during a scientific conference. However, this exception does not apply to seminars sponsored by pharmaceutical companies.

The second situation is the display, by a pharmaceutical company, of educational samples of an unapproved medicine at an exhibition during an international scientific conference – whether held inside or outside Japan – provided that Japanese medical professionals are in attendance. This is only allowed when the unapproved medicine has been approved in at least one other country. If the product has not been approved anywhere, the company may not display a sample. Furthermore, the company may not distribute samples of unapproved medicines or related scientific materials to anyone during the conference.

As mentioned in 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications, the Detailing Guidelines also set out certain conditions that must be met when providing information on unauthorised medicines or indications. These same conditions apply when such information is provided during a scientific conference.

The Commentary to the JPMA Promotion Code permits a pharmaceutical company to supply peer‑reviewed scientific journal articles – such as medical journal reprints – when they are requested by a medical doctor. However, companies must not proactively encourage or induce a medical doctor to request these scientific journal articles.

As mentioned in 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications, the Detailing Guidelines set out specific conditions under which information may be provided regarding unauthorised medicines or unauthorised indications.

There are no Japanese laws or self‑regulatory codes that expressly regulate the sending of information on unauthorised medicines or unauthorised indications to healthcare institutions for the purpose of enabling them to prepare budgets. Because no laws or self‑regulatory codes expressly permit such transmission of information, there remains a risk that this conduct could be regarded as a “promotional activity on unauthorised medicines or unauthorised indications”, which is prohibited under Article 68 of the PMD Act.

Japan’s compassionate use programme is intended to promote the expansion of clinical trials for patients who are interested in using unapproved products but are unable to join a clinical trial because they do not meet the inclusion criteria. This expanded trial system applies to investigational products that have completed, or are currently undergoing, a clinical trial in the final stage of development – generally, the Main Trials conducted to verify efficacy and safety after the indications, dosage and administration have been established through earlier studies.

To provide such patients with information on ongoing Main Trials or expanded trials, the PMDA will publish on its website certain details, including a description of the investigational product (investigational ingredient code), contact information for the trial sponsor, the subject disease, the phase of the clinical trial and the scheduled trial period. Provision of such information by pharmaceutical companies is allowed only “reactively” – that is, in response to an actual request from healthcare professionals, patients, or others – and must comply strictly with all requirements in the Detailing Guidelines, as explained in 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications. Accordingly, publication of such information by pharmaceutical companies is not permitted.

Advertising Prescription-Only Medicines

Advertising prescription-only medicines to the general public is prohibited in Japan. Article 5(1) of the MHLW Standards expressly prohibits such advertising. In addition, Article 67(1) of the PMD Act prohibits advertising drugs for specified diseases and regenerative medicines to the general public.

Advertising Over-the-Counter Medicines

Advertising OTC medicines to the general public is not prohibited, but it is restricted by the PMD Act and the MHLW Standards, as well as by self-regulatory codes.

Advertising for OTC medicines is subject to the rules concerning advertising under the PMD Act and the MHLW Standards, which are described in 1. Regulatory Framework. In this regard, Section 4, Article 6 of the MHLW Standards stipulates a particular restriction on advertisements to the general public concerning the efficacy of drugs for diseases that cannot be expected to be cured without a doctor’s or dentist’s diagnosis or treatment. This Article provides that any such advertisements targeted to the general public must not suggest that these diseases can be cured without such diagnosis or treatment.

In addition, the OTC Guidelines regulate advertising through newspapers, magazines, television, radio, websites and other forms of mainstream media to ensure the appropriateness of publicity and advertising activities for non-prescription drugs.

There is no law or regulation that specifies exactly what information must be included in pharmaceutical advertising aimed at the general public. However, under the PMD Act and the MHLW Standards, if advertising contains information such as product names, manufacturing processes, indications, dosage, administration or safety, the following rules must be observed.

• Companies must use only authorised brand names, generic names, or, for products that do not require marketing authorisation, names listed in the Japanese Pharmacopeia.
• Companies must describe the manufacturing process accurately and must not do so in a manner that could lead the general public to mistakenly believe the product has superior qualities.
• Section 4, Article 3 (1) and (4) of the MHLW Standards prohibit companies from using expressions that exceed or deviate from the authorised indication, dosage, administration or safety information of the products (ie, “off‑label promotion”).
• For products that do not require marketing authorisation, Section 4, Article 3 (2) and (4) of the MHLW Standards prohibit the use of expressions that exceed the scope of efficacy, dosage, administration or safety as generally recognised in the fields of medicine or pharmacy.
• The MHLW Standards also include several other relevant rules, such as prohibitions on certain efficacy or safety claims and prohibitions on slander or defamation of competitors’ products.

Beyond the question of what information must be included, the OTC Guidelines identify specific statements that are required or prohibited in advertisements for each category of OTC medicines. For example, advertisements for cold medicines must use the phrase “relief of cold symptoms” but may not include the statement “this will not make a patient sleepy.” Additionally, television advertisements or internet video advertisements for cold medicines must display the statement “this product shall be used only after receiving an explanation from a pharmacist and after carefully reading the warning label” for at least one second, using clear and distinct characters.

The price of the medicine may be mentioned in advertising aimed at the general public, although this is not required under any laws or self‑regulatory codes.

There are no laws or regulations that expressly impose restrictions on interactions between patients or patient organisations and industry.

The JPMA Code of Practice sets forth the rules concerning collaboration with patient groups. First, when a pharmaceutical company has any relationships or collaboration with patient institutions, the company must respect the independence of those institutions, and all company activities must adhere to high ethical standards. In addition, the company must make an effort to promote sufficient mutual understanding with patient groups regarding the purpose and scope of the collaboration.

Secondly, disclosure of sponsorship is required. The purpose and scope of the sponsorship must be agreed upon by both parties, documented in writing, and properly recorded to ensure transparency. Finally, member companies collaborating with patient organisations are required to establish internal company guidelines based on the “Guideline on Collaboration with Patient Organisations” issued by the JPMA.

There is no national law or regulation that explicitly specifies which information must be included in pharmaceutical advertising directed at healthcare professionals. However, if such advertising contains information relating to product names, manufacturing processes, indications, dosage, administration, safety, or other relevant items, it becomes subject to the MHLW Standards, as described in 4.2 Information Contained in Pharmaceutical Advertising to the General Public.

Regarding self‑regulatory codes, the JPMA Drafting Guidelines provide that advertising directed at healthcare professionals must, in principle, include the following information:

• name of the product (both brand name and generic name);
• therapeutic category;
• regulatory classification;
• indications;
• dosage/administration;
• warnings/contraindications/precautions;
• presence on the National Health Insurance (NHI) reimbursement price list;
• name of the marketing authorisation holder (including contact information and address for more product details);
• limitation of administration period;
• conditions for approval; and
• creation date of the advertisement.

Even if an advertisement is intended solely to promote the product name, it must still include at least the following: the product name (both brand and generic), therapeutic category, regulatory classification, presence on the NHI reimbursement price list, and the name of the marketing authorisation holder (with contact information and address).

Specific Prohibited Statements

In addition to specifying required information, the JPMA Promotion Code identifies statements that are prohibited in advertisements to healthcare professionals. For example, it forbids stating that “there are few adverse reactions” unless the conditions of use are cited or a summary of relevant data – including adverse reactions – is provided to substantiate the safety claim. The Code also aims to ensure the quality and clarity of the information presented. Advertising materials must not emphasise product efficacy without also including safety information, such as adverse reactions, to maintain a fair and balanced presentation. Furthermore, the contact information and address for additional product details must be clearly described.

Price

Advertising must indicate whether or not the medicine is listed on the NHI reimbursement price list, rather than providing the price itself.

Reference in pharmaceutical advertisements to data on file or to data generated from other clinical studies not included in the Summary of Product Characteristics is not prohibited. However, references to such data are limited in certain ways by law and by self‑regulatory codes.

First, the general rules on advertising under the PMD Act apply, such as the prohibition of false or exaggerated advertisements and the prohibition against advertising unapproved drugs or off‑label uses.

Secondly, references to data on file or generated from other clinical studies are subject to the specific regulations provided in the JPMA Drafting Guidelines. For example, statements may only concern indications approved in Japan. In addition, the study must have been published in a peer‑reviewed journal.

In Japan, combination products are treated as a single product (ie, pharmaceutical, medical device, or regenerative medicine product) and are assigned one “Summary of Product Characteristics”.

No specific rules exist for the advertising of companion diagnostic medicines. As companion diagnostic medicines are classified as medicines under the PMD Act, the advertising regulations that apply to medicines also apply to companion diagnostic medicines. The fact that a diagnostic is a companion diagnostic for a certain drug must be included in the Summary of Product Characteristics.

Reprints of journal articles for healthcare professionals are subject to the conditions set forth in laws, regulations, and self‑regulatory codes. Major restrictions on the distribution of reprints are as follows.

• The reprint must be authorised by the author(s) under copyright law.
• The contents of the journal article must not violate the PMD Act. In particular, the article must not contain false or exaggerated advertising, advertising that recommends unapproved drugs or off‑label uses, or advertising that slanders or defames competitors’ products.
• In principle, the reprint must relate to the company’s own product and be supplied in response to a request from a healthcare professional. In other words, a pharmaceutical company must refrain from actively inducing a healthcare professional to request such a reprint.

There is no national law or regulation in Japan that specifically refers to or governs the activities of Medical Science Liaisons (MSLs) or Medical Affairs (MA). However, in line with global practice, the number of pharmaceutical companies establishing MA divisions and MSL roles in Japan has been increasing in recent years. Against this backdrop, the JPMA issued a “Consensus Statement on Medical Affairs Activities” and a “Consensus Statement on Medical Science Liaison Activities” (“JPMA MSL Statement”).

In the JPMA MSL Statement, an MSL is defined as “a person who belongs to a division independent from the company’s commercial divisions and whose main role is to interact with external experts in the field of medicine or science.” The JPMA MSL Statement also states that MSL activities should not be aimed at promoting the sales of the company’s drugs.

As the definition indicates, the primary role of an MSL is to engage with external experts. However, this does not mean that MSLs are prohibited from responding reactively to requests from other healthcare professionals, including requests for information on unauthorised medicines or indications. When MSLs provide such information at the request of healthcare professionals, they must comply with the requirements set out in the Detailing Guidelines, as described in 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications.

In Japan, advertisements for medicines do not require prior authorisation from, nor notification to, any regulator. Management should establish a monitoring department within the company, independent of the department in charge of sales information provision activities, in order to ensure that these activities, including the MSL’s activities, are being properly carried out.

The Detailing Guidelines require companies to establish internal systems to ensure appropriate conduct in promotional activities. This includes creating a promotion supervisory department responsible for monitoring promotional materials and activities, which must operate independently from the company’s sales and marketing division. Companies must also set up a review and supervisory committee, which must include members who are independent of the company, to provide objective advice to the promotion supervisory department.

In addition, the Detailing Guidelines require:

• the preparation of standard operating procedures for promotional activities;
• the preparation and maintenance of business records (including records of any verbal explanations provided during detailing activities);
• the prior review and approval of marketing materials by the promotion supervisory department, based on advice from the review and supervisory committee;
• periodic training for both employees and officers; and
• the establishment of a telephone tip‑line to receive complaints regarding promotional activities.

The JPMA Promotion Code also requires that JPMA member companies:

• establish internal systems to comply with relevant laws, regulations, and industry self‑regulations;
• appoint a promotional material officer; and
• establish an internal oversight system to ensure that only reviewed promotional materials and advertisements are used.

Generally, the same laws, regulations, and self‑regulatory codes concerning pharmaceutical advertising apply to internet advertising for medical products. In addition, the Commentary to the JPMA Promotion Code provides specific rules regarding access restrictions for internet‑accessible information related to prescription‑only medicines.

Because advertising prescription‑only medicines to the general public is prohibited, when a pharmaceutical company provides healthcare professionals with product‑related information through the internet, the company must restrict access to those websites so that only healthcare professionals can view the information.

The key question, therefore, is: what constitutes a sufficient access restriction? In this regard, the Commentary states that an access restriction will be considered sufficient if all of the following conditions are satisfied.

• The name of the pharmaceutical company is provided, the website clearly states that the information is intended for healthcare professionals, and the person accessing the information understands that it is targeted at healthcare professionals.
• The information provided is appropriate for healthcare professionals.
• If a company website targeting healthcare professionals includes a link to an external website, both the content of the external website and the website itself must be appropriate for healthcare professionals, and the owner or author of the external website must be clearly identifiable.

As long as a pharmaceutical company implements a sufficient access restriction, it is not required to use any specific method for establishing passwords.

As mentioned in 7.1 The Advertisement of Medicinal Products on the Internet, pharmaceutical companies must include access restrictions on websites that contain advertising or other information intended for healthcare professionals. This requirement exists because advertising prescription‑only medicines to the general public is prohibited.

Generally speaking, the provision of disease awareness information and/or materials to patients online is subject to the same laws, regulations, and self‑regulatory codes that apply to such activities offline. As mentioned in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient‑Facing Information, the JPMA Code of Practice recommends that the content of disease awareness activities directed at ordinary citizens and patients be carefully reviewed from the planning stages to ensure that they are not considered prohibited advertising.

There are no specific laws, regulations or self-regulatory codes in Japan that address online scientific meetings. As a result, online scientific meetings would be subject to the same laws, regulations and self-regulatory codes that apply to in-person scientific meetings.

Generally, the same laws, regulations, and self‑regulatory codes that govern pharmaceutical advertising also apply to pharmaceutical advertising conducted through social media. In particular, the JPMA Code of Practice outlines several issues to which pharmaceutical companies must pay close attention when using social media for advertising purposes.

The JPMA Code of Practice defines “social media” as media created through interactive communication primarily via the internet, where users – including individuals – disseminate various kinds of information. A key feature of social media is that individuals can easily and quickly transmit information to the general public. Because of this characteristic, inappropriate or inaccurate information, including false information, may be widely circulated without verification. Consequently, the JPMA Code of Practice requires member companies to take full responsibility for such social media content. Before advertising on social media, companies must also ensure that all relevant subsidiaries, parent companies, affiliates, planning companies, agencies, employees, and others involved comply with the JPMA Code.

Furthermore, the JPMA Code of Practice requires member companies to pay particular attention to the following points.

• Compliance – the PMD Act and the MHLW Standards must be adhered to.
• Oversight – when a member company plans or supports social media activities, it is responsible for verifying the appropriateness of published content, including content posted by third parties. The company must take appropriate action – such as removing content – if inappropriate information is posted, including information on unapproved use, slander or defamation of other companies’ products, or information related to adverse events.
• Internal review – only information that has undergone careful scrutiny by the appropriate department within the company may be released.
• Transparency – when acting as a sponsor, the company must clearly indicate its company name.

Anti-bribery rules applicable to pharmaceutical companies and healthcare professionals or organisations are generally provided in the Penal Code (Act No 45 of 24 April 1907, as amended). In addition, pharmaceutical companies are expected to comply with the National Public Service Ethics Code (“Ethics Code”). Further, the Unfair Competition Prevention Act (Act No 47 of 19 May 1993, as amended) (UCPA) provides rules regarding bribery of foreign officials. These regulations apply only to benefits provided to individual recipients (eg, public officers).

Penal Code

Article 198 of the Penal Code is the basic anti-bribery regulation that directly applies to officers or employees of pharmaceutical companies. Article 198 provides that any person who gives, offers or promises to give a bribe to a public official shall be punished by imprisonment for not more than three years or a fine of not more than JPY2.5 million.

Bribery under the Penal Code is broadly defined. It covers not only money or goods but also any benefit (material or immaterial) sufficient to satisfy a person’s desires. “Public Official” is also broadly defined and includes not only national or local government officials but also individuals deemed government officials under special laws.

National Public Service Ethics Code

The Ethics Code is established by the Cabinet based on the National Public Service Act for the purpose of maintaining the integrity of, and citizens’ trust in, public service. The Ethics Code prohibits national public officials from receiving money or goods from interested parties. In some situations, pharmaceutical companies can be considered such “interested parties”.

The Ethics Code provides some exemptions, including:

• accepting gifts that are widely distributed to the public as promotional goods or souvenirs; and
• accepting souvenirs at a large dinner party.

Pharmaceutical companies are expected not to participate in conduct that would violate the Ethics Code, in order to prevent illegal acts by national public officers.

Unfair Competition Prevention Act

Article 18(1) of the UCPA prohibits any person from giving, offering or promising to give any benefit to a foreign public official to induce that official to act or refrain from acting in relation to their official duties, for the purpose of obtaining illicit gains in business regarding an international commercial transaction. Article 21(4)(iv) of the UCPA provides that an employee of a company who violates Article 18(1) shall be punished by imprisonment for up to ten years and/or a fine of up to JPY30 million. This also applies to foreign employees of Japanese entities who conduct such acts outside Japan. Further, the company itself may also be subject to a fine of up to JPY1 billion.

The UPMRA and the Fair Competition Code concerning Restrictions on Premium Offers in the Ethical Pharmaceutical Drugs Marketing Industry (the “Fair Competition Code”) regulate the offering of benefits and other inducements to healthcare professionals or organisations. The JPMA Promotion Code contains similar rules. These regulations apply to benefits provided to both individuals and organisations.

UPMRA

Article 4 of the UPMRA authorises the Prime Minister to restrict the offering of premiums in various ways, including through prohibition. Under Article 6(2) of the UPMRA, the Cabinet issued a public notice titled “Restrictions on the Offering of Premiums in the Ethical Pharmaceutical Drugs, Medical Devices and Sanitation Inspection Industries”. This notice prohibits pharmaceutical companies from offering articles, services, or other premiums to healthcare institutions as a means of inducing unjust transactions that exceed what is commercially reasonable for the usage or sanitary inspection of ethical pharmaceutical drugs.

Fair Competition Code

“Fair competition codes” are self‑regulatory frameworks established by business associations in specific industries based on UPMRA premium‑offering restrictions. Typically, these codes incorporate UPMRA rules and add supplemental provisions that reflect the nature of products and transactions within the relevant industry. The pharmaceutical industry has established the Fair Competition Code, which pharmaceutical companies currently follow.

According to the Fair Competition Code, pharmaceutical companies must not offer premiums to healthcare professionals or institutions for the purpose of unjustifiably inducing drug transactions. However, if such economic benefits align with standard commercial practices and are regarded as discounts, after‑sale services, or benefits related to the drugs themselves, they are not considered premiums. Additionally, even when money, goods, or economic benefits qualify as premiums, the Code permits certain offerings under specified circumstances (several examples are provided). Furthermore, if the premiums qualify as “small‑sum offerings”, providing them does not violate the Fair Competition Code.

The JPMA Promotion Code

The JPMA Promotion Code includes several provisions regarding the offering of benefits to healthcare professionals or institutions. It regulates, among other matters:

• the total amount of sample drugs that may be supplied;
• food, drinks, and gifts permitted in connection with lectures;
• gift‑giving practices; and
• the provision of cash or cash‑equivalent items that could negatively influence the proper use of drugs.

The Fair Competition Code and the JPMA Promotion Code regulate the offering of gifts to healthcare professionals.

The Fair Competition Code lists several examples of permitted gift‑giving activities, including:

• offers of articles or services that are necessary for the use of, or for enhancing the benefits of, ethical pharmaceutical drugs;
• offers of medical or pharmaceutical information on ethical pharmaceutical drugs; and
• offers of articles or services that are not considered extravagant or excessive in relation to seminars, or the payment of expenses for individuals to attend such seminars, which are organised for medical or other similar institutions in order to promote the understanding of certain ethical pharmaceutical drugs.

The JPMA Promotion Code prohibits member companies from offering healthcare professionals and medical institutions, among other entities, any goods that could potentially negatively affect the appropriate use of drugs or damage drug credibility.

The Fair Competition Code and the JPMA Promotion Code impose limitations on providing samples to healthcare professionals.

The Enforcement Rules and the Operating Standards of the Fair Competition Code set out the basic rules for offering samples of drugs. For product samples provided for reference, the following rules apply.

• The number of units of the drug contained in one package must not exceed the maximum allowed.
• The number of packages provided must be the minimum necessary for the purpose of supplying samples.
• If the drug is distributed through a wholesaler, the pharmaceutical company must designate the destination medical institutions.
• Pharmaceutical companies must supply the relevant drug information to the healthcare professionals receiving the samples.

Similar rules apply to the provision of clinical drug samples.

The JPMA Promotion Code further states that member companies must provide only the minimum amount of samples and must also include the relevant drug information.

Pharmaceutical companies are permitted to sponsor scientific meetings or congresses, as well as the attendance of healthcare professionals at such events, but only to a limited extent and in strict compliance with the Fair Competition Code and the JPMA Promotion Code.

With respect to seminars for healthcare professionals concerning a pharmaceutical company’s own drugs, the company may provide non‑extravagant articles or services and may bear certain related expenses. For example, companies may offer tea and snacks or lunch boxes, hold small social gatherings, cover transportation and accommodation costs, and compensate the lecturer.

The seminar must be held in an appropriate location for its intended purpose; therefore, it is advisable to avoid resorts, sightseeing destinations, or overseas venues. (The JPMA Promotion Code expressly states that pharmaceutical companies shall, in principle, hold such seminars in Japan.) Even if such seminars are permitted to take place abroad, payment of travel expenses must be limited to those of healthcare professionals who will provide information about the company’s drugs to all participants.

The rules under the Fair Competition Code set forth the types of entertainment/hospitality that pharmaceutical companies may or may not provide to healthcare professionals. By way of example, providing entertainment such as karaoke or golf is prohibited.

Pharmaceutical companies may provide grants or donations to healthcare professionals or healthcare institutions, subject to the restrictions set out in the Fair Competition Code and the JPMA Promotion Code.

Under the Fair Competition Code, pharmaceutical companies may not provide donations to healthcare professionals or healthcare institutions for the purpose of unjustly inducing drug transactions. Whether a donation has such a purpose is determined based on detailed criteria provided in the Operating Standards of the Fair Competition Code.

With regard to monetary donations, the Operating Standards specify that pharmaceutical companies may make monetary contributions to healthcare institutions within the bounds of standard commercial practice. Such donations are not regarded as unjust inducements for drug transactions.

With regard to non‑monetary donations, the Operating Standards allow pharmaceutical companies to voluntarily provide their own drugs to healthcare institutions in the event of a disaster, as well as to the medical faculties of universities, provided that the donation meaningfully contributes to student education.

Under the JPMA Promotion Code, pharmaceutical companies must not provide donations to healthcare professionals or healthcare institutions if such donations may influence the appropriate use of drugs.

In practice, pharmaceutical companies in Japan usually sell their drugs to wholesalers, who then sell the drugs to healthcare institutions. Since pharmaceutical companies generally do not sell directly to healthcare institutions, any rebates or discounts are typically provided to wholesalers rather than to healthcare institutions.

With respect to these rebates or discounts offered to wholesalers, the Anti-monopoly Act (Act No 54 of 14 April 1947, as amended) may prohibit certain conduct, such as adjusting the discount or rebate amount in exchange for the wholesaler’s agreement to follow a suggested price.

Under the Fair Competition Code, pharmaceutical companies may offer remuneration or cover expenses for research or certain types of studies. Expenses for post‑marketing surveillance of prescription‑only medicines and advertising fees for promoting drugs in journals are also permitted. All such payments must comply with the criteria specified in the Enforcement Rules and the Operating Standards of the Fair Competition Code. For example, remuneration must be appropriate in light of the nature and content of the research involved.

Similarly, the JPMA Promotion Code requires that any remuneration be appropriate in relation to the services actually provided. Pharmaceutical companies must not pay healthcare professionals for consulting services if the true purpose is to covertly provide prohibited monetary benefits.

No prior regulatory authorisations or notifications are required for the activities described in this section.

With regard to employer consent, pharmaceutical companies have internal rules that govern the provision of gifts, hospitality, donations, or other payments or services to healthcare professionals and institutions. These internal rules may require obtaining prior consent from, or providing notification to, the companies’ compliance divisions.

The Clinical Trials Act

The Clinical Trials Act (Act No 16 of 14 April 2017) requires pharmaceutical companies and their subsidiaries to disclose certain transfers of value to healthcare professionals and institutions in connection with specified clinical research. Clinical research includes human trials that examine the efficacy or safety of pharmaceuticals, but it does not include clinical trials for new drugs conducted under the PMD Act.

Specified clinical research is defined as clinical research funded by pharmaceutical companies, clinical research involving unapproved drugs, or clinical research concerning the off‑label use of a drug.

Transfers of value that must be disclosed under the Clinical Trials Act include research funds for specified clinical research, donations provided during the term of or within two years after the specified clinical research, and fees for writing, lectures, or other services provided during the term of and within two years after the specified clinical research. Recipients of payments covered by the regulation include healthcare providers involved in specified clinical research, healthcare institutions or other organisations to which a principal investigator belongs, and organisations managing the specified clinical research. Transfers of value for specified clinical research made in each fiscal year must be disclosed the following fiscal year on the company’s website.

The JPMA Transparency Guideline

The JPMA Transparency Guideline for the Relation between Corporate Activities and Medical Institutions (the “Transparency Guideline”) requires JPMA member companies to disclose certain information regarding transfers of value made to healthcare professionals or healthcare institutions.

The Transparency Guideline also requires each member company to establish its own internal “transparency policy” based on the guideline. As a result, every JPMA member company has created an internal transparency policy and has been disclosing information regarding transfers of value made to healthcare institutions in accordance with that policy.

Transfer categories

The Transparency Guideline outlines five categories of transfers of value (fees or expenses). Each category must be disclosed in detail. The five categories are:

• research and development expenses (such as expenses for clinical trials for new drugs);
• academic support expenses (such as donations to academic societies);
• manuscript/writing fees (such as fees for writing manuscripts containing scientific information about the company’s own drugs);
• expenses related to the provision of information (such as expenses for lectures and seminars); and
• other expenses (such as hospitality provided as a social courtesy).

Transfers of value to be disclosed include not only cash but also medicines, medical devices, and other goods. Value transferred through a third party – such as a subcontractor or foundation – must also be disclosed.

Recipients and disclosure

Recipients of payments covered by the Transparency Guideline include:

• healthcare institutions (such as hospitals and pharmacies);
• research institutes (such as medical and pharmaceutical departments of universities);
• healthcare associations (such as medical associations and pharmacists’ associations); and
• persons engaged in medical and nursing care (such as doctors and nurses) and life‑science researchers.

Transfers of value made in each fiscal year must be disclosed the following fiscal year on the company’s website.

As the transparency requirements under the Clinical Trials Act apply only to the marketing authorisation holder and its subsidiaries, these requirements do not extend to foreign companies or to companies that do not sell products on the Japanese market.

Similarly, the transparency requirements established under trade association rules – such as the Transparency Guideline (see 10.1 Requirement for Pharmaceutical Companies to Disclose Details of Transfers of Value) – bind only the members of those trade associations. Therefore, the self‑regulatory transparency obligations do not apply to foreign companies or companies without products on the market unless they are members of trade associations that impose such requirements.

Each Japanese law has one or more government agencies responsible for its enforcement (ie, the regulatory authority). For the PMD Act, as well as the MHLW Standards, the regulatory authorities are the MHLW and the competent prefectural governor. In the case of the UPMRA, the Prime Minister, the Consumer Affairs Agency, the Japan Fair Trade Commission and the competent prefectural governor are the regulatory authorities.

The main role of the courts in administrative law enforcement (including under the PMD Act) is to impose criminal penalties on companies and their employees that violate the law. In serious cases, the regulatory authority will request that the Public Prosecutor’s Office prosecute the company or employee. The Public Prosecutor’s Office will then file charges, and the court will render a final judgment.

With regard to the enforcement of self‑regulatory codes, the codes typically establish an organ responsible for enforcing the code. For the JPMA Promotion Code, the JPMA Code Compliance Committee serves this function. For the Fair Competition Code, enforcement is handled by the Fair Trade Council of the Ethical Pharmaceutical Drug Marketing Industry (the “Fair Trade Council”), which consists of the pharmaceutical companies designated by the code.

In Japan, pharmaceutical companies may initiate civil litigation proceedings against their competitors before the courts for certain types of advertising infringements under the UCPA.

Under the UCPA, a company whose business interests have been infringed, or are likely to be infringed, by a competitor’s dissemination of information or advertising that is likely to mislead the public as to the quality, content, or manufacturing method of its goods or services (UCPA, Article 2(1)(xx)), or by the announcement or dissemination of a falsehood injurious to its business reputation (UCPA, Article 2(1)(xxi)), may seek an injunction against the competitor to suspend or prevent the infringement (UCPA, Article 3(1)).

The company may also claim damages for harm to its business interests resulting from intentional or negligent infringement related to the above conduct.

For example, a pharmaceutical company may file a lawsuit in a Japanese court seeking an injunction and/or compensation for damages against a competitor if the competitor creates an advertisement containing falsehoods or slander regarding the pharmaceutical company’s products.

Penalties or Measures Imposed by Regulators

In practice, Japanese regulatory authorities – such as the MHLW or the Prime Minister – will typically issue administrative “guidance” as an initial response to a violation by a pharmaceutical company. This guidance is essentially an official request to correct the unlawful conduct. If the company fails to follow such guidance, the authority may then issue an administrative “disposition”.

Under the PMD Act, the MHLW or the competent prefectural governor may impose the following administrative dispositions, among others.

• Order a pharmaceutical company that has violated the PMD Act to comply with a “business improvement order” (eg, an order to improve internal review systems for advertisements) (Article 72-4).
• Order a pharmaceutical company that advertised a pharmaceutical product before obtaining the required marketing authorisation – which is prohibited under Article 68 – to take measures to prevent recurrence (Article 72-5).
• Withdraw a pharmaceutical company’s manufacturing and/or marketing licence or suspend all or part of its business for a period determined by the MHLW if the company has violated the PMD Act (Article 75).

In addition, as mentioned in 1.1 Laws and Self‑Regulatory Codes Concerning the Advertisement and Promotion of Medicines, the PMD Act includes administrative fines for false or exaggerated advertising and provides for cease‑and‑desist orders against companies engaging in such improper advertising.

A company whose manufacturing and/or marketing licence has been withdrawn may appeal the disposition under the Administrative Appeal Act (Act No 160 of 15 September 1962, as amended).

The JPMA Code Compliance Committee

The JPMA Code Compliance Committee may take actions against pharmaceutical companies that violate the JPMA Promotion Code, in accordance with the “Rules of Actions against the Breach of the Code of Practice.” Possible measures include, among others, a serious warning, suspension of membership, or expulsion from the JPMA.

The Fair Trade Council

The Fair Trade Council may order companies that violate the Fair Competition Code to take corrective measures. If a company fails to comply, the council may impose penalties, including a fine of up to JPY1 million or expulsion from the council. The council may also request that the Consumer Affairs Agency take necessary action.

Penalties Imposed by Courts

Courts may impose criminal penalties on pharmaceutical companies, as well as on their officers and employees, for violations of relevant laws. Major criminal sanctions for breaches of pharmaceutical advertising rules and rules on inducements to prescribe include the following.

• False or exaggerated advertising and advertising for an unauthorised drug: imprisonment for up to two years and/or a fine of up to JPY2 million (PMD Act, Article 85).
• Advertising to the general public pharmaceutical products intended for the cure of cancer, sarcoma, or leukaemia: imprisonment for up to one year and/or a fine of up to JPY1 million (PMD Act, Article 86).
• Violation of a cease‑and‑desist order issued by the Secretary General of the Consumer Affairs Agency: imprisonment for up to two years or a fine of up to JPY3 million (UPMRA, Article 46).
• Bribery of a public official: imprisonment for up to three years or a fine of up to JPY2.5 million (Penal Code, Article 198).
• Bribery of a foreign public official: imprisonment for up to ten years and/or a fine of up to JPY30 million (UCPA, Article 21(4)(iv)).

While only individuals are subject to criminal sanctions under the Penal Code, both individuals and companies may be sanctioned under the PMD Act, the UPMRA, and the UCPA (PMD Act Article 90(ii), UPMRA Article 49(1), and UCPA Article 22(1)(i)).

The procedures before and measures taken by the self-regulatory authority and the courts are conducted separately and independently.

The MHLW is strengthening its enforcement activities related to pharmaceutical advertising. In 2016, the MHLW began monitoring the advertising of ethical drugs in order to identify violations early and to encourage pharmaceutical companies and trade associations to take voluntary corrective measures. This initiative included appointing an anonymous healthcare institution to identify problematic items in advertisements and promotional information provided by pharmaceutical companies, including on their websites and in specialist journals.

On 1 October 2019, the MHLW expanded this monitoring activity to include voluntarily submitted information from any healthcare institution. As a result of these monitoring efforts, the MHLW identified 18 possible violations, including 23 problematic items, in 2024.

In addition, as noted in 1.1 Laws and Self‑Regulatory Codes Concerning the Advertisement and Promotion of Medicines, the PMD Act provides for administrative fines for violations of regulations concerning false or exaggerated advertising, as well as cease and desist orders for pharmaceutical companies engaged in improper advertising. As of 15 January 2026, no administrative fines have been imposed under these provisions.

As veterinary medicines are included in the definition of “medicines” under the PMD Act, the same advertising regulations under the PMD Act apply to veterinary medicines. The difference is that, for veterinary medicines, the regulatory authority is not the MHLW but the Ministry of Agriculture, Forestry and Fisheries (MAFF) and the competent prefectural governors. MAFF has issued the “Standards for Appropriate Advertising Concerning Veterinary Medicine” (Notification 12 Chiku A No 728 of the Livestock Industry Bureau of 31 March 2000). Similar to the MHLW Standards, the MAFF standards list prohibited expressions in advertisements, including language that is misleading as to the effectiveness of the medicine or that denigrates other companies.

While the regulatory body is different, the enforcement measures that may be taken under the PMD Act by MAFF in respect of veterinary medicines are the same as those taken by the MHLW for human medicines.

The views and opinions set forth herein are the personal views or opinions of the authors; they do not necessarily reflect the views or opinions of the law firm with which they are associated.