Regulatory compliance: overview

1. What is the situation?

Internal whistleblowing, advertising and representations, questions of price and payment with a business that carries out entrusted work, and excessive demands from customers: this page points to the guides that relate to the situation. It is not a complete list of the areas of regulation.

In considering a response, the points to have in order are the facts in question, the persons involved, any notice received, and the deadline for replying. These are points to check according to the matter. There is no statutory sequence of steps common to every case.

2. Guides by area of regulation

The guides below concern areas of regulation in which the authorities may give guidance, make a recommendation or take similar steps, and set out what is expected of a business in response.

• Internal whistleblowing and the amended Whistleblower Protection Act — the arrangements for receiving reports and the development of internal arrangements, the persons covered, and the protection of the person who reports. How the facts reported are then established is covered by the guide on internal investigations into suspected misconduct.
• Advertising rules for pharmaceuticals, cosmetics and medical institutions — advertising of products such as pharmaceuticals and cosmetics, and advertising by hospitals, clinics and other medical institutions, with the rules and the response set out for each.
• Payment and pricing in entrusted business transactions — whether the legislation applies to the transaction, consultations about price, and the payment or reduction of the fee.
• Responding to harassment of employees by customers — responding to excessive demands and conduct from customers and business partners, and developing a policy, arrangements for consultation and procedures for handling such conduct so as to protect employees.

From October 1, 2026, an employer is required to take the measures necessary in employment management so that the working environment of the workers it employs is not harmed by conduct in the workplace of customers and others that goes beyond what is socially accepted in light of the nature of the work performed by those workers and other circumstances. Those measures include developing arrangements to respond appropriately to consultations from the worker concerned, and measures to deter such conduct that are necessary to secure the effectiveness of the response to conduct of customers and others that harms the working environment. Even before that date, a response based on the employer's duty of care for safety and similar obligations may be required.

3. Where an internal investigation or dealing with the authorities follows

Where the facts said to constitute a breach need to be established, or where preserving evidence and the arrangements for an investigation need to be considered, see also the guide on internal investigations into suspected misconduct. We do not recommend an internal investigation, or the establishment of a third-party investigation committee, in every matter. A third-party investigation committee is an arrangement used in Japan under which a company entrusts the investigation of suspected misconduct to outside members who have no interest in the company, and the committee conducts the investigation and reports on its own responsibility.

Where an authority makes an inquiry, requests a report or carries out an on-site inspection, we point to Responding to Regulatory Investigations and Dawn Raids, which covers the initial response and the handling of the investigation. What is required differs according to the legislation the authority relies on, whether there is an obligation to answer or to produce materials, and whether the matter is an administrative investigation or a criminal procedure.

4. Responding in related disputes

• Ending a business relationship and refusing to renew a contract — the conditions on which a transaction may be brought to an end, refusal to renew, and the settlement of accounts and damages that follow termination.
• Responding to shareholder claims and disputes over control of the company — claims by shareholders, litigation and provisional dispositions concerning the position of an officer, and responding where the liability of an officer is pursued. A provisional disposition is an order of a Japanese court that regulates the position of the parties on a provisional basis while the main proceedings are pending.

5. Making an inquiry

We advise companies, other legal entities and their executives on regulatory matters. Depending on the matter and the scope of the instructions, our work runs from organizing the facts at the initial stages of our work on the matter, through developing and reviewing internal arrangements and responding to an investigation, to responding in related disputes.

Key legislation and official sources

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

Where it appears	Legislation	Source type
Whistleblowing arrangements and the protection of the person reporting (section 2)	Whistleblower Protection Act（公益通報者保護法）	Japanese legislation / English translation / Official guidance
Advertising of pharmaceuticals, cosmetics and related products (section 2)	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
Advertising by hospitals, clinics and other medical institutions (section 2)	Medical Care Act（医療法）	Japanese legislation / English translation
Representations as to quality and as to advantage in advertising (section 2)	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
Employment management measures concerning conduct of customers and others (section 2)	Act on Comprehensively Advancing Labor Measures, and Stabilizing the Employment of Workers, and Enriching Workers' Vocational Lives（労働施策の総合的な推進並びに労働者の雇用の安定及び職業生活の充実等に関する法律）	Japanese legislation / English translation
The duty of care for safety (section 2)	Labor Contracts Act（労働契約法）	Japanese legislation / English translation

Legal information reviewed: 2026-09-18

Contact

Making an inquiry

Please tell us the outline of the situation, any notice you have received and its date, and any deadline you are working to.

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Related Services

Related Crisis Management Topics

Internal whistleblowing and the amended Whistleblower Protection Act

Covers, from the position of a company that has received an internal report, whether the report amounts to whistleblowing under Japan's Whistleblower Protection Act, the reporting channels, designated handlers and internal arrangements, personnel measures after a report, and the transitional provisions of the amended Act.

Responding to harassment of employees by customers

Covers responding to excessive demands and conduct from customers and others, and developing internal arrangements to protect employees.

Regulatory compliance (practice areas)

Our practice areas relating to developing compliance policies, procedures and organizational arrangements and internal controls, internal investigations, and dealing with the authorities.

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.