Japan

Advertising regulation in Japan

Regulator: MHLW ／ Basis: 医薬品医療機器等法（薬機法）

Claims of efficacyExpressions of the efficacy, effect or performance of a product requiring approval must not exceed the scope of the approved indications, whether explicit or implicit, and expressions guaranteeing efficacy or using superlatives are prohibited.
Comparative advertisingProduct-to-product comparative advertising is limited to the advertiser's own products with the comparator product named, and comparative advertising against other companies' products is prohibited whether explicit or implicit.
Safety informationIn sales information provision activities a company must provide necessary safety information including adverse reactions, not efficacy alone, and must not select the information it provides arbitrarily.
Direct-to-consumerAdvertising aimed at the general public other than healthcare professionals is prohibited for medicines and regenerative medical products supplied for use by a physician or dentist or on their prescription or instruction.
Materials for HCPsInformation provided in sales information materials must stay within the approved indications, dosage and administration, must rest on scientific and objective evidence that a third party can objectively evaluate and verify, and must state the source of any material quoted.
Pre-clearanceSales information materials must be reviewed before use by an in-house promotional information supervision department that is set up independently of the promotional department, and that department approves them taking into account advice from a review and supervision committee.
Digital and socialThe Standards for Fair Advertising of Drugs and Related Products apply to advertising in all media, including newspapers, magazines, television, radio, websites and social networking services.
EnforcementA person who violates the prohibition on false or exaggerated advertising in Article 66(1) is liable to imprisonment of up to two years or a fine of up to 2 million yen or both (Article 85 item 4), and the Minister must order payment of a surcharge of 4.5 percent of the total consideration for the products traded during the surcharge period of up to three years, except that no order may be made where the calculated amount is under 2.25 million yen. Separately from punishment and the surcharge, Article 72-5(1) empowers the Minister or the prefectural governor to order a person who has violated Article 66(1) or Article 68 to cease the act, to take the measures necessary to prevent its repetition, to give public notice in connection with those measures, and to take any other measures sufficient to prevent the occurrence of a danger to public health; such an order may be issued even where the violation has already ceased, and may be directed not only at the violator but also at a corporation surviving or created by merger, a corporation succeeding to the business by company split, and a transferee of the business. Article 72-5(2) allows the Minister or governor to request a specified telecommunications service provider to take measures to prevent the transmission of an unlawful advertisement sent by specified telecommunications. A person who disobeys an Article 72-5(1) order is liable under Article 85 item 6 to imprisonment of up to two years or a fine of up to 2 million yen or both.

Every cell carries a summary, a source and a date checked. Topics whose source has not been verified are left marked “not researched” rather than filled with plausible text. Directives and statutes bind as to the result; what applies in practice is national implementing law. This is a research aid, not legal advice.