REGULATIONS UNDER PHARMACEUTICAL AFFAIRS AND MEDICAL DEVICES ACT

Checked and updated: October 11, 2026.
Scope of this review: criminal and administrative measures, the surcharge system, and the Supreme Court decision in the Diovan case. Primary sources are listed below.

REGULATIONS UNDER PHARMACEUTICAL AFFAIRS AND MEDICAL DEVICES ACT

The relevant provisions of the Pharmaceuticals and Medical Devices Act pertaining to advertisement of pharmaceuticals are as follows:

Relevant Provisions	Description
Article 66 Prohibition of false and exaggerated advertisement	Prohibition of advertisement, descriptions, and dissemination of false and exaggerated articles on the names, manufacturing methods, indications, effects, and performance of pharmaceuticals, etc. Prohibition of advertisement, descriptions, and dissemination of articles that may cause misunderstanding that physicians, etc. guarantee the efficacy, efficacy, and performance of pharmaceuticals, etc. Prohibition of use of implication of abortion and use of obscene documents and drawings.
Article 67 Restriction on advertisement of designated pharmaceuticals, etc.	Restriction of advertisement of pharmaceuticals, etc. to the general public other than healthcare professionals used for the treatment of cancer and other special diseases specified by Cabinet Order
Article 68 Prohibition of advertisement of pharmaceuticals prior to approval	Prohibition of advertisements on the names, manufacturing methods, indications, effects, and performance of pharmaceuticals prior to approval or certification.

Definition of Advertisement

Advertisement for pharmaceuticals in the Pharmaceuticals and Medical Devices Act is defined as follows by the notice issued by the Ministry of Health, Labour and Welfare (“MHLW”).

1. clearly intended to induce consumers to purchase products (or intended to enhance motivation of customers to purchase products);
2. present the commercial name and class clearly such as specified pharmaceuticals; and
3. is accessible to general public.

"Applicability of Advertisement of Pharmaceuticals, etc. in the Pharmaceutical Affairs Act (Notice No. 148 of the Inspection and Guidance Division, Pharmaceutical and Medical Safety Bureau, MHLW, dated September 29, 1998)" Generally, the requirement (1) (2) (3) are referred as “induction”, “speficificity”, and “accessibility”. In the Diovan case, the Tokyo High Court dismissed the prosecution's appeals on November 19, 2018. On June 28, 2021, the First Petty Bench of the Supreme Court dismissed the further appeals. The following list summarizes the requirements as discussed in the 2018 High Court judgment.

1. Induction

   (a) [Objective Induction] The fact that the notification act has the nature of a means of indusing customers to purchase in view of the contents and format thereof; and (b) [Subjective Induction] The intention of the actor to utilize the notification itself as a means of indusing customers to purchase.

2. Specificity

   The specific pharmaceuticals etc., are specified in the notification. In determining whether this specification has been made, consideration should be given to whether or not the product name, common name, abbreviation, etc. is displayed, as well as the media used for notification and the attributes of the notifyee.

3. Accesibility

   To be notified (or planned to be notified) to an unspecified or large number of persons

Supplement: Supreme Court decision
Interpreting Article 66(1) of the Pharmaceutical Affairs Act as it stood before the 2013 amendment, the Supreme Court held that the regulated conduct involves informing an unspecified or large number of people of the prescribed matters as a means of encouraging the purchase or prescription of particular pharmaceuticals. Whether a communication has that character is assessed objectively in light of its content, nature, manner and other circumstances. The publication of the papers in specialist academic journals in this case did not fall within the provision. This finding was based on the facts of the case and does not establish a blanket exemption for academic papers. Supreme Court decision, 2018 (A) No. 1846 (Japanese)

Standards for proper advertisement of Pharmaceuticals

As mentioned above, there are only three provisions that directly regulate advertisement of pharmaceuticals under the Pharmaceuticals and Medical Devices Act. In light of the essence of pharmaceuticals etc., Standards for Proper Advertisement of Pharmaceuticals, etc. (the “Standards for Proper Advertisement”) provide the explanation of Article 66, Paragraph 1 of the Pharmaceuticals and Medical Devices Act, as well as the items to be observed with respect to pharmaceuticals, etc. so as not customers to misuse, promote abuse, or not to reduce the credibility of pharmaceuticals etc.

Applicable Advertisement	Advertisement in all media, including newspapers, magazines, televisions, radios, websites, and social networking services
Responsibility of the Advertiser	To endeavor to communicate accurate information so that users can use pharmaceuticals properly Prohibition of advertisements that may impair the dignity of pharmaceuticals or jeopardize the credibility of pharmaceuticals
Manufacturing Method	Prohibition of expressions that differ from actual manufacturing methods or that may give contradictory recognition to the facts about their superiority.
Efficacy, Performance, and Safety	Prohibition of expressions exceeding the range of approved indications, etc. Prohibition of advertisements using false or inaccurate expressions of ingredients and quantities that may contradict the facts about their indications or safety Prohibition of advertisements using wordings that goes beyond the approved range or inaccurate wordings that may contradict the facts about efficacy or safety Prohibition of expressions guaranteeing efficacy or safety Prohibition of maximum expressions regarding efficacy or safety Prohibition of expression of quick-acting, long-acting, etc. that exceeds medically-or-pharmaceutically-recognized range Prohibition of expressions not deemed to be original indications, etc.
Other	Prohibition of advertisement that may encourage overconsumption or abuse Prohibition of advertisement of ethical pharmaceuticals to the general public Prohibition of advertisement to defame other companies' products Prohibition of expressions recommendations by healthcare professionals, etc.

SANCTIONS FOR NON-COMPLIANCE

(1) Criminal measures

A violation of Article 66(1) (false or exaggerated advertising) or Article 68 (advertising before approval) is punishable by a custodial sentence (拘禁刑) of up to two years, a fine of up to JPY 2 million, or both (Article 85, items 4 and 5). If a corporation's representative, agent, employee or other worker commits the violation in connection with its business, the corporation is also subject to a fine of up to JPY 2 million (Article 90, item 2).

Manufacturing and marketing pharmaceuticals without the required approval in violation of Article 14(1) is a separate offense, punishable by a custodial sentence of up to three years, a fine of up to JPY 3 million, or both (Article 84, item 3). If a corporation's representative, agent, employee or other worker commits such a violation in connection with its business, the corporation is subject to a fine of up to JPY 100 million (Article 90, item 1).

The replacement of imprisonment with work (懲役) by the new custodial sentence (拘禁刑) took effect on June 1, 2025. Transitional provisions must be checked for conduct occurring before that date.

(2) Administrative measures

The Minister of MHLW may order the marketing authorization holder of pharmaceuticals to take the measures necessary to improve its operations if the marketing authorization holder of pharmaceuticals has violated the provisions of the Pharmaceutical and Medical Devices Act or orders based thereon when necessary to prevent the occurrence or spread of health and hygiene hazards (orders for improvement of operations, Article 72-4, Paragraph 1). The Minister of MHLW or a prefectural governor may order a person who violates Article 66(1) or Article 68 to stop the violation, prevent recurrence, give public notice, or take other necessary measures (Article 72-5(1)). An order may also be issued after the violation has ceased.

ACTUAL EXAMPLES OF ILLEGAL ADVERTISEMENT

MHLW judged that Takeda Pharmaceutical Company's promotional materials for Blopress, a treatment for hypertension, constituted an exaggerated advertisement under Article 66, Paragraph 1 of the Pharmaceuticals and Medical Devices Act, and in June 2015 MHLW issued the order for improvement of operations in accordance with Article 72-4, Paragraph 1 of the Act. This was the first case in which MHLW issued an administrative disposition in violation of Article 66 of the Pharmaceuticals and Medical Devices Act due to the exaggerated advertisement. Among the promotional materials for Blopress, in addition to the catch copy "it is preferable to have more cards", there were five cards labeled "CKD," "diabetes," "nocturnal hypertension," "elderly” and “OVER 140/90." These were judged as an exaggerated advertisement of Blopress because it implies an indication other than "hypertension," which was the approved indication of Blopress. In addition, Takeda’s advertisement material was judged to be an exaggerated advertisement since the material emphasized the superiority of Blopress by adding arrows that gave an impression of significant difference and expressing the crossing-over as "golden cross while the results of clinical trials (CASE-J trial) comparing the effects of Blopress with other companies' antihypertensive pharmaceuticals showed no significant difference each other.

SURCHARGES FOR FALSE OR EXAGGERATED ADVERTISING

(1) Introduction and commencement

The surcharge system was introduced by the amendment promulgated on December 4, 2019, and took effect on August 1, 2021. It addresses economic gains from violations separately from criminal penalties and administrative measures.

(2) Amount and assessment period

For a violation of Article 66(1), the Minister of MHLW must, in principle, order payment of a surcharge equal to 4.5% of the total consideration for transactions in the relevant pharmaceuticals during the assessment period (Article 75-5-2(1)).

The assessment period generally covers the period of the violation. If relevant transactions occur within six months after the violation ceases (or up to and including the date of the prescribed measures to eliminate the risk of misunderstanding, if earlier), the period extends to the last such transaction. If the resulting period exceeds three years, the last three years apply (paragraph 2).

(3) Cases in which payment is not ordered

No payment order may be issued if the amount calculated under Article 75-5-2(1), before the reductions described below, is less than JPY 2.25 million (paragraph 4).

The Minister may refrain from ordering payment when issuing an improvement or corrective order and the impact on the occurrence or spread of public health hazards is considered minor, or when imposing a disposition under Article 75(1) or Article 75-2(1), such as revocation of a license (Article 75-5-2(3)). Such a disposition does not automatically exempt a person from a surcharge.

(4) Coordination with the Premiums and Representations Act and voluntary reporting

For the same conduct, if a surcharge payment order has been issued under Article 8(1) of the Act against Unjustifiable Premiums and Misleading Representations, or no payment is to be ordered under Article 11 of that Act, an amount equal to 3% of the total consideration is deducted from the PMD Act surcharge (Article 75-5-3).

Reporting the relevant facts to the Minister in the prescribed manner results in a 50% reduction of the applicable amount. This does not apply to a report made in anticipation of a payment order because an investigation has taken place (Article 75-5-4).

Primary sources checked for this update

• PMD Act: corrective orders, surcharges and criminal penalties (Japanese)
• PMD Act: Article 90, penalties for corporations (Japanese)
• Commencement dates of the amended PMD Act (Japanese)
• MHLW notice on the new custodial sentence (Japanese)
• Diovan case: Supreme Court decision of June 28, 2021 (Japanese)