Updated weekly ・ last 2026-10-03JAEN
Pharma Promotion / Japan

Promotion of prescription medicines — Japan

Regulator: 厚生労働省・PMDA ／ Main law: 医薬品医療機器等法（薬機法）・医療用医薬品の販売情報提供活動に関するガイドライン

Japan ad-regulation library — guides on Japanese rules, material review and authoring, ethics and history.

The basics (source-verified)

Pre-review & approval

Sales 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.

Source: 医療用医薬品の販売情報提供活動に関するガイドライン（平成30年9月25日 薬生発0925第1号）（checked 2026-09-23）

Promotion to HCPs

Information 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.

Source: 医療用医薬品の販売情報提供活動に関するガイドライン（平成30年9月25日 薬生発0925第1号）（checked 2026-09-23）

Direct-to-consumer

Advertising 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.

Source: 医薬品等適正広告基準の改正について（平成29年9月29日 薬生発0929第4号）別紙「医薬品等適正広告基準」（checked 2026-09-23）

Digital & social media

The 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.

Source: 医薬品等適正広告基準の改正について（平成29年9月29日 薬生発0929第4号）別紙「医薬品等適正広告基準」（checked 2026-09-23）

Efficacy claims

Expressions 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.

Source: 医薬品等適正広告基準の改正について（平成29年9月29日 薬生発0929第4号）別紙「医薬品等適正広告基準」（checked 2026-09-23）

Safety information

In 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.

Source: 医療用医薬品の販売情報提供活動に関するガイドライン（平成30年9月25日 薬生発0925第1号）（checked 2026-09-23）

Comparative claims

Product-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.

Source: 医薬品等適正広告基準の解説及び留意事項等について（平成29年9月29日 薬生監麻発0929第5号）（checked 2026-09-23）

Enforcement & penalties

A 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.

Source: 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（昭和35年法律第145号）第66条・第68条・第72条の5・第72条の6・第75条の5の2・第85条（checked 2026-09-23）

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