1. Advertising, sales information and product information

For advertising classification, approved uses, promotional materials and sales information, including U.S. regulatory and enforcement resources.

• PMD Act — statutory text (e-Gov)

  Statutory text ｜ Japanese ｜ e-Gov Law Search (Digital Agency)
  Check the applicable effective-date version in e-Gov

  Check statutory provisions on pharmaceutical advertising and compliance systems for marketing authorization holders and manufacturers.

• MHLW: Official Advertising and Sales Information Provision Materials

  Official resource index (HTML) ｜ Japanese ｜ Ministry of Health, Labour and Welfare (MHLW)
  Updated resource index, rather than a fixed edition

  Find advertising notices, the surcharge system, sales-information Q&A and annual reports from FY2016 onward.

• Standards for Appropriate Advertising of Pharmaceuticals and Related Products

  Director-General notification and advertising standards (PDF) ｜ Japanese ｜ Ministry of Health, Labour and Welfare (MHLW)
  Notification dated 29 September 2017

  Check MHLW standards when reviewing efficacy and safety claims and advertising directed at healthcare professionals.

• Explanatory Notes on the Appropriate Advertising Standards

  Division Director notification and explanatory notes (PDF) ｜ Japanese ｜ Ministry of Health, Labour and Welfare (MHLW)
  Notification dated 29 September 2017

  Consult MHLW explanations when applying individual advertising standards to claims and promotional materials.

• Notification on What Constitutes Pharmaceutical Advertising

  Division Director notification (PDF) ｜ Japanese ｜ Ministry of Health and Welfare (hosted by MHLW)
  Notification dated 29 September 1998

  Check the three criteria used to assess whether a communication constitutes pharmaceutical advertising.

• PMDA: Prescription drug information search

  Official database ｜ Japanese ｜ Pharmaceuticals and Medical Devices Agency (PMDA)
  Continuously updated

  Search product-specific labels, approval assessments, RMPs and appropriate-use materials.

• Guidelines on Sales Information Provision Activities for Prescription Drugs

  Director-General notification and guidelines (PDF) ｜ Japanese ｜ Ministry of Health, Labour and Welfare (MHLW)
  Notification dated 25 September 2018

  Check standards for sales information, internal controls and handling unapproved or off-label information.

• Sales Information Provision Guideline Q&A No. 3

  Administrative communication and Q&A (PDF) ｜ Japanese ｜ Ministry of Health, Labour and Welfare (MHLW)
  6 September 2019

  Check conditions for providing stability information on simple suspension and crushing through interview forms and related disclosures.

• Sales Information Provision Guideline Q&A No. 4

  Administrative communication and Q&A (PDF) ｜ Japanese ｜ Ministry of Health, Labour and Welfare (MHLW)
  21 February 2024

  Check conditions for product comparisons and responding to requests for off-label information.

• FY2025 Sales Information Provision Activities Survey Report

  Commissioned survey report (PDF) ｜ Japanese ｜ MHLW-commissioned report / Mitsubishi UFJ Research and Consulting
  March 2026 (FY2025 report)

  Review reported concerns, case assessments and survey findings when assessing materials and activities.

• Reporting Portal for Pharmaceutical Advertising Activities

  Entry page for a commissioned project’s reporting portal (HTML) ｜ Japanese ｜ Referred by MHLW / Secretariat: Mitsubishi UFJ Research and Consulting
  No fixed edition or revision date stated (checked 11 October 2026)

  Find the reporting portal and reporting procedures for sales information provision activities that may be inappropriate.

• JPMA Code of Practice

  Self-regulatory code and index of Japanese and English PDFs ｜ Japanese and English ｜ Japan Pharmaceutical Manufacturers Association (JPMA)
  Revised May 2025 / effective 1 October 2025

  Check JPMA members’ self-regulatory standards for promotion and interactions with healthcare professionals and other stakeholders.

• JPMA Guidelines for Preparing Product Information Brochures and Explanatory Notes

  Index of self-regulatory preparation guidelines and annotated PDFs ｜ Japanese ｜ Japan Pharmaceutical Manufacturers Association (JPMA)
  October 2023 revision

  Review brochure content and advertising materials against JPMA’s self-regulatory preparation standards.

• FDA OPDP: Prescription-drug promotion regulatory information

  Foreign promotion rules and guidance index ｜ English ｜ U.S. Food and Drug Administration, OPDP
  Ongoing official index; checked 11 October 2026

  Find U.S. laws, regulations and guidance governing prescription-drug advertising and promotional labeling.

• FDA: Warning and Untitled Letters to pharmaceutical companies

  Official enforcement-letter index ｜ English ｜ U.S. Food and Drug Administration
  Ongoing official index; checked 11 October 2026

  Use enforcement letters to identify problematic promotional claims for internal review and training.

2. Benefits and public service ethics

For benefits, donations, research payments, meals and interactions with Japanese national public officials.

• Act against Unjustifiable Premiums and Misleading Representations (e-Gov)

  Statutory text ｜ Japanese ｜ e-Gov Law Search (Digital Agency)
  Check the applicable effective-date version in e-Gov

  Check statutory rules on premiums and representations and the framework for approving fair competition codes.

• CAA: Fair Competition Code System

  Explanatory webpage (HTML) ｜ Japanese ｜ Consumer Affairs Agency (CAA)
  No revision date stated on the page

  Understand how industry rules are approved as fair competition codes under the Premiums and Representations Act.

• Pharmaceutical Fair Trade Council: Notices, Code, Rules and Operational Standards

  Index of notices, approved industry code and operational standards ｜ Japanese ｜ Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry
  Code effective 1 October 2024 / five revised operational standards effective April 2026

  Check legal restrictions and industry rules on benefits, donations, commissioned research and company-sponsored meetings.

• Overview of Revised Meals and Hospitality Rules (April 2026)

  Official revision overview (PDF) ｜ Japanese ｜ Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry
  April 2026 (rules applying from 1 April 2026)

  Compare changes to meals and hospitality rules for product briefings and lectures before and after April 2026.

• Pharmaceutical Companies and the Fair Competition Code: Q&A (July 2023; 10th edition, partially revised)

  Public practical Q&A (PDF) ｜ Japanese ｜ Fair Trade Council of the Ethical Pharmaceutical Drugs Marketing Industry
  July 2023; 10th edition, partially revised

  Review practical questions about benefits, donations, research payments and joint meetings alongside the current Code and operational standards.

  This Q&A dates from 2023; also check the current Code and operational standards, including the 2026 revisions.

• National Public Service Ethics Board: Act, Code and Explanatory Materials

  Official index of legislation, guidance and training materials ｜ Japanese ｜ National Personnel Authority / National Public Service Ethics Board
  Updated resource index, rather than a fixed edition

  Find legislation, explanations and cases relevant to interactions and benefits involving national public servants.

• National Public Service Ethics Act and Code Q&A

  Official Q&A webpage (HTML) ｜ Japanese ｜ National Personnel Authority / National Public Service Ethics Board
  No revision date stated on the page

  Check basic questions on interested parties and rules for gifts, meals and other interactions.

• National Public Service Ethics Code: Issues and Casebook (2023 revised edition, ver. 3)

  Official interpretation and casebook (PDF) ｜ Japanese ｜ Secretariat of the National Public Service Ethics Board (National Personnel Authority)
  Revised March 2023; supplemented July 2024; partly amended May 2025 (ver. 3)

  Consult updated issues and examples when assessing gifts, meals and services involving national public servants.

3. Payment disclosure, research and patient information

For payments to medical institutions and patient organizations, clinical research, research ethics and patient-data handling.

• Clinical Trials Act (Japanese statutory text)

  Statute ｜ Japanese ｜ Japan (published by MHLW)
  Act No. 16 of 2017; consult the amendment history and supplementary provisions.

  Check the statutory scope and procedures for clinical research and the legal framework for industry funding and disclosure.

• Regulation for Enforcement of the Clinical Trials Act (Japanese)

  Ministerial ordinance ｜ Japanese ｜ Ministry of Health, Labour and Welfare (MHLW)
  MHLW Ordinance No. 17 of 2018, including amendments effective 31 May 2025.

  Check the detailed implementation standards, conflict-of-interest procedures and filing and disclosure requirements under the Act.

• MHLW: Clinical Trials Act amendments, notices and Q&A

  Official legislation, notices and guidance index ｜ Japanese, with links to selected reference translations ｜ Ministry of Health, Labour and Welfare (MHLW)
  Continuously updated; includes the 2025 amendments and the COI-management notice applicable from 20 April 2026.

  Find explanations and Q&A for the 2025 amendments together with the 2026 conflict-of-interest notice and forms.

• JPMA: Transparency Guideline for Medical Institutions

  Industry voluntary standard ｜ Japanese and English ｜ Japan Pharmaceutical Manufacturers Association (JPMA)
  Revised 1 April 2026; the March 2025 edition is also available.

  Check the disclosure categories and timing for payments to medical institutions and health care professionals, including research funding, donations and fees.

  Disclosure of advertising fees and supporting membership fees added in 2026 applies to payments in company fiscal years beginning in January 2027 or later.

• JPMA: Patient Organization Transparency Guideline and disclosures

  Industry voluntary standard and member disclosure index ｜ Japanese; the English site carries an automatic-translation notice ｜ Japan Pharmaceutical Manufacturers Association (JPMA)
  Guideline revised and effective 25 May 2022; the index includes FY2025 payment disclosures.

  Check disclosure standards for direct and indirect support, fees and services to patient organizations, and locate member companies' disclosures.

• JPMA: Guidelines on Collaboration with Patient Organizations

  Industry voluntary standard ｜ Japanese; the English site carries an automatic-translation notice ｜ Japan Pharmaceutical Manufacturers Association (JPMA)
  Revised and effective 25 May 2022.

  Check standards for independence, advance written agreements, information provision and restrictions on promotion and influence in patient collaborations.

• MEXT: Ethical Guidelines for Medical and Biological Research Involving Human Subjects

  Official ethical-guideline and guidance index ｜ Japanese; reference English translation of the 2023 edition ｜ MEXT, MHLW and METI (index published by MEXT)
  Current edition: amended 27 March 2023. The 27 August 2026 amendment takes effect on 1 December 2026. Posted guidance revised 1 April 2024.

  Find the current ethical-review, consent and specimen/data rules alongside the text and comparison table for the December 2026 amendment.

  The 2026 amendments are not yet in force as of the review date. Check study-specific transitional provisions; the English reference translation is the 2023 edition.

• MHLW: jRCT — Japan Registry of Clinical Trials

  Public study registry and search database ｜ Japanese, with an English display option; content depends on the registered record ｜ Ministry of Health, Labour and Welfare (MHLW)
  Continuously updated; moved to the current domain in March 2025.

  Search publicly registered study plans, status and study-management information for clinical trials and clinical research in Japan.

• PPC / MHLW: Personal Information Guidance for Medical and Care Providers

  Government guidance ｜ Japanese ｜ Personal Information Protection Commission (PPC) and MHLW
  Partially revised April 2026.

  Check guidance on patient-data use, security, third-party disclosure and overseas transfers in medical and care settings.

  Guidance for medical and care providers; also useful when considering counterparties’ practices in medical-data collaborations and research contracts.

• CMS: Open Payments program overview

  Government program information ｜ English ｜ Centers for Medicare & Medicaid Services (CMS), United States
  Page last modified 30 June 2026; announces Program Year 2025 data.

  Understand who reports payments, who is covered and how the US disclosure cycle works.

• CMS: Search and Download Open Payments Data

  Public payment-data search and download guide ｜ English ｜ Centers for Medicare & Medicaid Services (CMS), United States
  Guide last modified 5 May 2026; Program Year 2025 data is available.

  Find provider and company payment searches, filtered exports and full datasets by program year.

  Listing a payment does not itself establish a violation or conflict of interest.

4. Domestic and international anti-bribery

For Japanese, U.S. and UK anti-bribery frameworks, dealings with foreign public officials and historical enforcement cases.

• Penal Code — statutory text (e-Gov)

  Statutory text ｜ Japanese ｜ e-Gov Law Search (Digital Agency)
  Check the applicable effective-date version in e-Gov

  Check statutory provisions governing bribery of public officials and receipt of bribes.

• Unfair Competition Prevention Act — statutory text (e-Gov)

  Statutory text ｜ Japanese ｜ e-Gov Law Search (Digital Agency)
  Check the applicable effective-date version in e-Gov

  Check statutory provisions restricting improper benefits provided to foreign public officials.

• METI: Foreign bribery prevention resources

  Official administrative resources index ｜ Japanese ｜ Ministry of Economy, Trade and Industry (METI)
  Continuously updated; includes the February 2024 guidelines

  Find the foreign-bribery framework, prevention guidelines, practical materials and consultation information.

• METI: Guidelines for the Prevention of Bribery of Foreign Public Officials

  Administrative guidelines (PDF) ｜ Japanese ｜ METI
  Revised February 2024

  Review voluntary and preventive corporate approaches to preventing foreign public official bribery.

• DOJ/SEC: FCPA Resource Guide and FEPA addendum

  Official legal guidance and document index ｜ English; Spanish edition also linked ｜ U.S. Department of Justice and SEC
  Second edition: July 2020; FEPA addendum: 13 December 2024

  Check FCPA coverage and accounting provisions alongside FEPA rules addressing foreign officials’ demands for bribes.

  For enforcement policy, also consult the 2025 FCPA guidelines and the 2026 CEP listed below.

• DOJ: FCPA investigation and enforcement guidelines

  Prosecutorial enforcement policy ｜ English ｜ U.S. Department of Justice
  9 June 2025

  Check DOJ priorities and decision-making guidance for FCPA investigations and enforcement.

• SEC: FCPA enforcement actions

  Official enforcement index ｜ English ｜ U.S. Securities and Exchange Commission
  Ongoing index; latest listed cases observed: 2024

  Review historical FCPA cases and SEC orders for bribery, accounting and internal-control issues.

• UK Bribery Act 2010: official statutory text

  Foreign legislation ｜ English ｜ UK legislation database (The National Archives)
  2010 Act; effective 1 July 2011

  Check UK bribery offences and the corporate failure-to-prevent offence and adequate-procedures framework.

• UK Ministry of Justice: Bribery Act Guidance

  Statutory anti-bribery procedures guidance ｜ English ｜ UK Ministry of Justice
  Document: March 2011; landing page updated 22 January 2025

  Design risk-based anti-bribery procedures and understand the adequate-procedures framework.

5. Compliance systems and corporate responses

For internal controls, training and audit, and for self-disclosure, cooperation and remediation after misconduct is identified.

• MHLW: Compliance guidelines for marketing authorization holders and manufacturers

  Administrative guidance (PDF) ｜ Japanese ｜ MHLW
  29 January 2021

  Review governance, responsible officers, internal rules, training, audit and reporting arrangements.

• MHLW: Q&A on the compliance guidelines

  Administrative Q&A (PDF) ｜ Japanese ｜ MHLW
  8 February 2021

  Check mandatory and recommended measures and the roles of responsible officers and statutory managers.

• JPMA: Charter of Corporate Behavior and related materials

  Official industry voluntary standards index ｜ Japanese ｜ Japan Pharmaceutical Manufacturers Association (JPMA)
  Charter revised 18 October 2018; implemented 1 April 2019

  Review principles for ethical and transparent pharmaceutical business conduct and sustainable development.

• JPMA: Compliance Programme Guidelines

  Industry voluntary standard ｜ Japanese ｜ Japan Pharmaceutical Manufacturers Association (JPMA)
  Revised 13 March 2023

  Review the framework for member companies to establish and operate corporate compliance programmes.

• HHS-OIG: General Compliance Program Guidance

  Voluntary, nonbinding government guidance ｜ English ｜ HHS Office of Inspector General
  November 2023

  Review healthcare compliance infrastructure and principal U.S. federal-law risks.

• HHS-OIG: Compliance Program Guidance for Pharmaceutical Manufacturers

  Industry-specific government guidance ｜ English ｜ HHS Office of Inspector General
  Published 5 May 2003

  Review pharmaceutical payment and marketing risks when designing an industry-specific compliance program.

  Sector-specific guidance issued in 2003; read alongside the 2023 General Compliance Program Guidance.

• USSC Guidelines Manual: 2025 edition

  Sentencing guidelines and official commentary ｜ English ｜ U.S. Sentencing Commission
  Effective 1 November 2025

  Check organizational sentencing rules and the elements of an effective compliance and ethics program.

• USSC adopted amendments: scheduled for 1 November 2026

  Adopted amendments, not yet effective ｜ English ｜ U.S. Sentencing Commission
  Scheduled for 1 November 2026; not yet effective on the review date

  Prepare for forthcoming sentencing amendments while keeping them separate from the current 2025 Manual.

• DOJ: Evaluation of Corporate Compliance Programs

  Prosecutorial evaluation guidance and official index ｜ English ｜ U.S. Department of Justice, Criminal Division
  September 2024 edition

  Assess program design, resources and practical effectiveness against DOJ evaluation criteria.

• DOJ: Department-wide CEP, voluntary disclosure and monitor policies

  Prosecutorial policies and official update index ｜ English ｜ U.S. Department of Justice
  CEP: 10 March 2026; index updated 21 July 2026

  Check voluntary disclosure, cooperation and remediation expectations and monitor policy updates after misconduct.

• UK SFO: Evaluating a Corporate Compliance Programme

  Investigative and prosecutorial evaluation guidance ｜ English ｜ UK Serious Fraud Office
  26 November 2025

  Check how the SFO assesses whether a corporate compliance programme works in practice.

• UK SFO: Corporate self-reporting and cooperation guidance

  Corporate cooperation and enforcement guidance ｜ English ｜ UK Serious Fraud Office
  24 April 2025

  Check how corporate self-reporting, evidence preservation and cooperation inform consideration of a DPA.

6. Overseas and international industry codes

For HCP and patient-organization interactions, international events, fees, disclosure and digital communications.

Core overseas and international resources

• PhRMA: Code on Interactions with Health Care Professionals

  U.S. pharmaceutical industry code ｜ English ｜ Pharmaceutical Research and Manufacturers of America
  Revised August 2021; effective 1 January 2022

  Check U.S. pharmaceutical industry standards for healthcare-professional meetings and related interactions.

• EFPIA Code of Practice: 2026 consolidated version

  European pharmaceutical industry code ｜ English ｜ European Federation of Pharmaceutical Industries and Associations
  2026 consolidated version

  Check European industry standards for stakeholder interactions and disclosure of transfers of value.

• EFPIA: Country meal and drink thresholds

  Country-specific industry-code reference ｜ English ｜ European Federation of Pharmaceutical Industries and Associations
  Updated 13 July 2026

  Check host-country industry-code meal thresholds when planning cross-border meetings and hospitality.

• IFPMA Code of Practice 2019: including Q&A and 2021 update

  International pharmaceutical industry code ｜ English; Japanese and other translations also linked ｜ International Federation of Pharmaceutical Manufacturers and Associations
  2019 edition; section 7.3 updated April 2021

  Check international industry standards for interactions with healthcare professionals, institutions and patient organizations.

• IFPMA: Patient and Patient Organization Interactions

  Industry-code guidance ｜ English ｜ International Federation of Pharmaceutical Manufacturers and Associations
  16 March 2020

  Check industry-code considerations for collaboration with and support for patients and patient organizations.

• IFPMA: Fees for Services guidance (2020 update)

  Industry-code guidance ｜ English ｜ International Federation of Pharmaceutical Manufacturers and Associations
  4 February 2020 update

  Check industry-code considerations when paying fees for services such as speaking engagements.

• IFPMA: Educational and Scientific Events guidance (2026 update)

  Industry-code guidance ｜ English ｜ International Federation of Pharmaceutical Manufacturers and Associations
  5 June 2026 update

  Apply the IFPMA Code when organizing or supporting educational and scientific events for healthcare professionals.

• IFPMA: Continuing Medical Education guidance

  Industry-code guidance ｜ English ｜ International Federation of Pharmaceutical Manufacturers and Associations
  5 December 2018

  Check considerations for funding and supporting continuing medical education.

• IFPMA/EFPIA: Social Media and Digital Channels guidance

  Joint industry-code guidance ｜ English ｜ IFPMA and EFPIA
  28 September 2022

  Check industry guidance for communicating pharmaceutical information through social media and digital channels.