Advertising rules for pharmaceuticals, cosmetics and medical institutions

1. Which advertising is covered and which law applies: product advertising, medical advertising and the rules on representations

The first point to check is whether the representation in question is product advertising subject to the pharmaceuticals and medical devices legislation, medical advertising subject to the medical care legislation, or both. Which of these it is changes both the expressions that are prohibited and the way the authorities become involved.

Whether something is advertising of pharmaceuticals and related products is judged by whether the intention to attract customers is clear, whether the name of a particular product is identifiable, and whether it is in a state in which members of the general public can perceive it (the requirements set out in the notification of September 29, 1998 on whether advertising of pharmaceuticals and related products falls within the Pharmaceutical Affairs Act). This is the framework for assessment set out in that notification. The pharmaceuticals and medical devices legislation covers not only false or exaggerated "advertising" but also "describing" and "disseminating". The application of that legislation is not avoided merely because something does not take the form of an advertisement.

Whether something is medical advertising is judged by whether there is an intention to attract patients to seek treatment, whether the provider of the medical care or a similar party can be identified, and whether the content relates to medical or dental practice or to a hospital or clinic.

For facilities that patients use in order to receive online medical care, a separate provision of the medical care legislation applies to advertising about the facility itself. That provision has been in force since April 1, 2026. Matters such as stating clearly in the advertising that the facility does not itself provide medical care are laid down by ministerial ordinance. Because different provisions apply to advertising about the medical care that can be received at such a facility and to advertising about the facility itself, these are checked separately.

The legislation on premiums and representations applies both to advertising of pharmaceuticals and related products and to advertising by medical institutions. It covers not only representations that indicate that something is significantly superior to what it actually is (misleading representations as to quality), but also representations that create a significantly mistaken impression of advantage as to price or terms of trade (misleading representations as to advantage). In addition, a representation that is not clearly identifiable to general consumers as a representation made by a business is in itself treated as an unjustifiable representation. Since October 1, 2024, provisions imposing criminal penalties directly in respect of misleading representations as to quality and as to advantage have also been in place. Separately from checking the pharmaceuticals and medical care legislation, representations of prices and discount terms, and representations that appear to come from a third party, are therefore also checked.

2. Advertising rules under the pharmaceuticals and medical devices legislation: efficacy claims, false or exaggerated advertising, and advertising before approval

For product advertising, the first things to check are the legal classification of the product in question and whether approval or certification is required. The framework of the efficacy and similar claims that may be made differs according to whether the product is a pharmaceutical, a quasi-pharmaceutical product, a cosmetic or a medical device. On that basis, the rules that depend on who is expressing the claim and on whom the advertising is directed to, and the prohibition on advertising before approval, are checked.

Advertising, describing or disseminating a false or exaggerated account of the name, method of manufacture, efficacy, effects or performance of pharmaceuticals and related products is prohibited, whether the account is explicit or implicit. This prohibition applies to any person and is not directed only at marketing authorization holders. It cannot be taken as a matter of course that the provision does not apply to advertising agencies, retailers, affiliate publishers or others, depending on the capacity in which they are involved in the representation.

Advertising, describing or disseminating an account that is liable to give rise to the misunderstanding that a physician or another person has guaranteed the efficacy, effects or performance of pharmaceuticals and related products is treated as falling within the prohibition on false or exaggerated advertising. Because this is a deeming provision, the question is whether the account is liable to give rise to the misunderstanding that there has been such a guarantee.

Separately from this, the standards for proper advertising of pharmaceuticals and related products state that, as a general rule, advertising to the effect that medical professionals, or public offices, schools, organizations or other bodies whose views have a considerable influence on perceptions of the efficacy of pharmaceuticals and related products, have designated, publicly approved, recommended, instructed on or selected a product is not to be carried out. This includes cases where the designation or recommendation is factually correct. Exceptions are provided for in certain cases, but this is a different standard from whether something is taken as a guarantee, so each is checked separately. These standards are set out in a notification, and whether conduct falls foul of them is considered separately from whether it breaches a statutory prohibition that attracts a criminal penalty.

For products that require approval or certification, expressions that go beyond the scope of the efficacy and effects for which approval was granted may be an issue as false or exaggerated advertising. Whether a particular expression stays within that scope is checked against what is stated in the approval documents. By contrast, for cosmetics, which do not require approval, there are no approval documents to compare against. What is checked is whether the claims made about the product stay within the efficacy claims that may be made for cosmetics, as set out by the Ministry of Health, Labour and Welfare.

Even where an expression is within the scope of the approval, advertising may not be possible depending on whom it is directed to and in which medium it appears. The standards for proper advertising of pharmaceuticals and related products state that advertising of prescription pharmaceuticals and similar products directed at the general public is not to be carried out. The pharmaceuticals and medical devices legislation also restricts advertising directed at members of the general public other than medical professionals for those pharmaceuticals and related products intended for use against cancer or other specified diseases that are designated by cabinet order. Who the medium in question is read by, and whether distribution is limited to a defined audience, are also checked.

Advertising the name, method of manufacture, efficacy, effects or performance of a pharmaceutical, medical device or regenerative medical product before it has received the approval or certification required by the pharmaceuticals and medical devices legislation is prohibited. What is covered are pharmaceuticals, medical devices and regenerative medical products that require approval or certification and have not yet received it. Cosmetics and quasi-pharmaceutical products cannot be treated as subject to this restriction across the board.

3. Medical advertising: prohibited advertising, advertisable matters and lifting of the limitation

For medical advertising, the sequence is to consider whether the advertising falls within one of the prohibited categories, then whether it stays within the range of advertisable matters, and, if it does not, whether the conditions for lifting that limitation are met.

In medical advertising, false advertising is prohibited, as is advertising to the effect that a hospital or clinic is superior to others, and exaggerated advertising. Advertising whose content is contrary to public order and morals, and advertising that does not meet the standards laid down by ministerial ordinance, are also listed. It cannot be read as meaning that everything not listed is permitted.

Advertising of accounts of personal experience, based on the subjective impressions or hearsay of patients or others, concerning the content or effects of treatment must not be carried out. This is a prohibition that applies to advertising that is subject to the rules. It does not as a matter of course prohibit every posting that a patient makes independently, but where the medical institution has requested or been involved in the posting, the assessment of whether it is advertising may change. Separate standards apply to before-and-after photographs of treatment. What is prohibited are photographs that are liable to cause patients or others to be mistaken as to the content or effects of treatment, and the posting of before-and-after photographs is not prohibited across the board.

To include matters other than advertisable matters in medical advertising, the conditions for lifting the limitation laid down by ministerial ordinance must be met, such as that the information appears on a website or similar medium that patients obtain of their own accord, and that contact details are clearly stated. Where information is provided about treatment outside the public health insurance system, information must also be provided about the content and cost of the treatment normally required, and about the main risks and side effects. Lifting the limitation widens the range of matters that may be included; it does not lift the prohibitions on false or exaggerated advertising or on advertising of accounts of personal experience.

Even so, a representation is not automatically eligible for the lifting of the limitation merely because it appears online. Banner advertisements, and sponsored listings displayed in search results, cannot be said to be information that patients obtain of their own accord, and so do not meet the conditions. Nor is the information required about cost and about risks and side effects for treatment outside the public health insurance system satisfied by listing the items as a formality. The content of the treatment, the standard cost, and the period and number of sessions are to be presented in a layout in which patients can take them in.

Where information is provided about treatment outside the public health insurance system using unapproved pharmaceuticals or related products, further information is required in addition to the ordinary conditions for lifting the limitation. This includes the fact that the product used has not been approved in Japan, the route by which it is obtained, whether there are domestically approved products with the same or similar efficacy, information on safety in other countries, and the fact that the treatment is not covered by the Adverse Drug Reaction Relief System and similar schemes. This information may also be required where a product approved in Japan is used outside the scope of its approval, and such cases are not all outside the scope of the requirement. Meeting the conditions for lifting the limitation as a matter of medical advertising and being able to advertise an unapproved product under the pharmaceuticals and medical devices legislation are separate questions.

4. Initial response when a violation is alleged: preserving the published content and supporting materials, and deciding on corrections

Where a violation is alleged, correcting the representation and preserving the state it was in before the correction are done at the same time. Making the correction does not bring the subsequent procedures to an end.

Who has raised the point, and in what form, is also checked. An approach from a consumer or a business partner, a voluntary inquiry or a request for improvement from an administrative authority, and a request for a report or for the production of materials based on legislation differ both in whether there is a time limit and in what a reply means. What is checked is not only the title of the document but also what is cited in it as the basis for the request.

When advertising is amended or taken down, the content as published, the period of publication and the materials supporting the representation are preserved. This is a matter of practice; there is no single provision that requires all of this to be preserved across the board. Taking a publication down and deleting the records of it are separate tasks. Alongside stopping publication, the screens, the copy data and the distribution settings as they were before the amendment or removal are preserved. This does not mean that advertising that raises a problem should continue to be published while the preservation work is carried out.

In order to decide whether a representation is a misleading representation as to quality, an administrative authority may require the business to produce materials showing reasonable grounds supporting the representation. Where the business does not produce materials, or where the materials produced are not found to show reasonable grounds, the representation is deemed to be a misleading representation as to quality for the purposes of an order to take measures, and is presumed to be a misleading representation as to quality for the purposes of an order to pay a surcharge. Because deeming and presuming have different effects, which of these procedures the materials are being sought for is checked. The period for producing the materials is, as a general rule, 15 days, and the need to carry out new tests or studies is not treated as a justifiable reason for extending that period. Since materials cannot be assembled from scratch once they are requested, the grounds for a representation are to be in place by the time publication begins.

Even where advertising in breach of the pharmaceuticals and medical devices legislation has already been stopped, measures such as steps to prevent recurrence or public notice may be ordered. What is covered are acts in breach of the prohibition on false or exaggerated advertising or of the prohibition on advertising pharmaceuticals and related products before approval, and the legislation provides that an order may be made "even where the act in breach has already ceased". Those to whom such an order may be addressed include, in addition to the party that committed the breach, a corporation surviving a merger or established by a merger, a corporation that has succeeded by company split to all or part of the business concerned, and a party that has acquired that business. Removing the advertising does not necessarily bring the procedure to an end.

5. Administrative action, surcharges and criminal liability: differences between the regimes

This chapter sets out which procedures attach to which breaches. The provisions that can give rise to an order and the provisions to which criminal penalties attach directly are not the same.

Prefectural governors and other competent authorities may order that advertising be stopped or corrected within a set period where it breaches the standards on the content or method of advertising, or the limitation on advertisable matters. These are the breaches listed as grounds for an order; the prohibition on false advertising as such is not among them. Even so, where false advertising is suspected, prefectural governors and other competent authorities may require a report or carry out an on-site inspection. The fact that a breach is not listed as a ground for an order does not mean that the authorities have no role.

False medical advertising is subject to imprisonment for not more than six months or a fine of not more than 300,000 yen, without any need for a breach of an order to stop or correct the advertising. The penal provisions are structured differently as between the provision that punishes the breach of the prohibition on false advertising itself and the provision that punishes a breach of an order to stop or correct advertising. This is a description of the penalties laid down by law, and does not mean that a penalty will be imposed as soon as a point is raised.

Where a representative of a corporation, or an employee or other person acting for it, commits a breach consisting of false medical advertising in connection with the business of the corporation, the corporation as well as the person who committed the breach is subject to a fine. What is covered is a breach in connection with the business of the corporation, and it does not follow that every corporation involved in the advertising is punished. The position is checked corporation by corporation.

For advertising in breach of the prohibition on false or exaggerated advertising under the pharmaceuticals and medical devices legislation, there is a surcharge regime. The amount of the surcharge is, as a general rule, an amount equivalent to 4.5 per cent of the total consideration for the products concerned traded during the surcharge period. Where the amount calculated in this way is less than 2.25 million yen, payment may not be ordered. That question is decided on the amount before any adjustment against the premiums and representations legislation and before any reduction for voluntary reporting. Separately from this, payment may be ordered not to be made where the conditions laid down by law are met. It does not follow that a surcharge is imposed generally for a breach of the prohibition on advertising pharmaceuticals and related products before approval.

The period covered by the surcharge is based on the period during which the breach was committed, subject to an upper limit of three years. Transactions after the breach has ceased may fall within that period to a certain extent. There is also a reduction where a breach is reported voluntarily, but a report made in anticipation of being ordered to pay a surcharge because an investigation has begun does not qualify. Separately from this, payment may not be ordered once five years have passed since the day the breach ceased. The determination of the period covered and this limitation period are checked separately.

Where an order to pay a surcharge under the premiums and representations legislation has been made in respect of the same conduct by the same business, 3 per cent of the total consideration is deducted from the surcharge under the pharmaceuticals and medical devices legislation. The same applies where, as a result of refund measures carried out under an approved plan under that legislation, payment is ordered not to be made. This is not a provision under which the amount actually paid under the premiums and representations legislation is deducted as such.

A person who breaches the prohibition on false or exaggerated advertising or the prohibition on advertising pharmaceuticals and related products before approval under the pharmaceuticals and medical devices legislation is liable to imprisonment for not more than two years or a fine of not more than 2 million yen, or both. This is a penalty imposed on the person who committed the act, and is distinct from the provisions imposing liability on a corporation as well. Nor does the fact that advertising has been questioned lead directly to the conclusion that an offense has been committed.

6. Reviewing advertising review arrangements, and how we assist

Correcting individual expressions on their own leaves a risk that the same problem recurs. The premiums and representations legislation requires businesses to put in place arrangements for managing representations properly.

A business is required to put in place the arrangements necessary for managing representations properly, and to take other necessary measures, in relation to transactions in the goods and services it supplies. What is covered are representations about the goods and services the business itself supplies. Not everyone involved in advertising is under the same duty. The company decides who checks representations, at what stage and on what basis, and considers how to keep a record of those checks.

We assist companies and medical institutions with checking advertising representations, with the initial response where a point is raised, with corrective measures and with dealings with the authorities, to the extent of the instructions we are given. We do not guarantee that particular advertising is lawful or that no action will be taken.

Key legislation and official sources

English translations of legislation are provided for reference. The Japanese texts are authoritative.

Where it appears	Legislation	Source type
False or exaggerated advertising; accounts liable to be taken as a guarantee; advertising before approval; restrictions on advertising to the general public	Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices（医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律）	Japanese legislation / English translation
Orders where the act in breach has already ceased; surcharges, the surcharge period and adjustments	Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices（医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律）	Japanese legislation / English translation
Efficacy claims that may be made for cosmetics	Ministry of Health, Labour and Welfare, scope of efficacy claims for cosmetics	Official guidance
Prohibited medical advertising; advertisable matters; orders to stop or correct advertising; reports and on-site inspections; penalties	Medical Care Act（医療法）	Japanese legislation / English translation
Advertising about facilities used to receive online medical care	Medical Care Act（医療法）	Japanese legislation / English translation
Misleading representations as to quality and as to advantage; representations not identifiable as advertising; production of materials showing reasonable grounds; orders to take measures and surcharges; arrangements for managing representations	Act against Unjustifiable Premiums and Misleading Representations（不当景品類及び不当表示防止法）	Japanese legislation / English translation

Legal information reviewed: 2026-09-18

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This article is provided for general informational purposes only and does not constitute legal advice on any specific matter. Please consult us regarding your specific situation. The content is based on the laws and regulations in effect as of the date of the last update.