Pharmaceutical Association of Japan PV Navi
The Green Book and other PV-related "guides" are posted by category. Please bookmark this page and make active use of it in your PV work.
Please select the category you wish to view and click the "Select" button.
The Green Book and other guidance documents may not reflect the latest notifications, etc. Please be sure to check the publication date.
Please be sure to check the publication date, and if necessary, refer to the original text of the notices, etc. at the following sites.
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As of December 2023The Green Book is a guide prepared by the Pharmaceutical Manufacturers Association of Japan (PMAJ) based on notifications, etc. for each type of work, the contents of which are discussed with the regulatory authorities. Various PV-related guidance, etc. other than the Green Book are referred to as the White Book.
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As of December 2023Documents that cover multiple categories are listed in duplicate.
(e.g., "Guidance for preparation of electronic adverse drug reaction/infection case reports, etc." is listed at both
"3. Accumulation evaluation/periodic reporting/post-marketing surveillance" and "4. Adverse drug reaction reports" because it includes contents of unknown/non-serious adverse drug reaction reports in addition to adverse drug reaction reports)
1 RMP (Risk Management Plan)
The Green Book and other guidance documents may not reflect the latest notifications, etc. Please be sure to check the publication date.
Please be sure to check the publication date, and if necessary, refer to the original text of the notices, etc. at the following sites.
Click here to see the past history
- RMP training slides for MRs (revised August 2025)
- RMP/ RMP material utilization case studies - mainly for dispensing pharmacies - (January 2025)
- RMP Follow-up Survey (1st interim results)
- Explanation of RMP Mark (Revision 2024) - For identification of materials based on additional risk minimization activities
- Comparative survey on the status of development of additional risk minimization activities in Japan, the U.S., and Europe (November 2023)
- RMP Training Slides for MRs" and "Overview Version_RMP Explanation Slides by MRs (Slide Template for RMP Explanation to Medical Institutions)" (May 2023)
- Pharmaceutical Risk Management Plan (RMP): Considerations for Evaluating the Effectiveness of Additional Risk Minimization Activities (Materials), Version 2 (April 2022)
- Maintenance of J-RMPs as Seen from Company Case Studies - Proposals for Appropriate Drug Risk Management (March 2022 edition) (March 2022)
- Considerations for Developing Additional Risk Minimization Activities in the Pharmaceutical Risk Management Plan (RMP) (October 2019)
- Considerations for Developing a Pharmaceutical Risk Management Plan (RMP) Based on Utilization by Healthcare Professionals (March 2017)
- Developing a Pharmaceutical Risk Management Plan: An Introduction (December 2016)
- A Study on Benefit-Risk Assessment of Post-Marketing Drugs, From the Results of IMI-PROTECT (July 2016)
- Establishing Safety Considerations and Research Questions (Research Questions) for Scientific Drug Risk Management Plan (RMP) Practice (August 2014)
Click here to see the past history
- Reflections on the first 10 years since the introduction of the RMP system from the pharmaceutical industry's perspective
- Preparation of "Collection of Case Studies of Utilization of RMP/RMP Materials" Presentation slides (19th Annual Meeting of the Japanese Society of Pharmacy)
- Presentation slides "Efforts of the pharmaceutical industry to promote utilization of RMP/RMP materials" (July 5, 2025, 27th Annual Meeting of the Japanese Society for Pharmaceutical Informatics)
- General introduction of RMP (including the latest information on the revision of medical fees, etc.) (November 3, 2024, Japan Society of Medical Pharmacy Slide)
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2. re-examination/re-evaluation
The Green Book and other guidance documents may not reflect the latest notifications, etc. Please be sure to check the publication date.
Please be sure to check the publication date, and if necessary, refer to the original text of the notices, etc. at the following sites.
- Guidance for Periodic Safety Reporting - Gateway System Use - (May 2024)
- Guidance for Application for Reexamination - Gateway System Use ver. 2.0 (March 2024)
- Guidance for Conformity Survey for Reexamination (October 2025)
- Guidance for Remote Investigation (Reexamination) Ver. 3.0 (April 2024)
- Guide to Viewing the "Video on Reexamination Compliance Surveillance" distributed by PMDA (February 2025)
- Guidance on Procedures for Lifting Conditions of Approval for Post-Marketing Surveillance, etc. / Explanation of "Q&A on Use-results Surveillance of Ethical Drugs by the All Patient Surveillance Method" (October 2024)
Click here for past history
Click here for past history
- Leaflet on the use-results survey for patients "Do you know about the 'use-results survey' conducted by pharmaceutical companies?
- Post-marketing clinical trials other than post-marketing clinical trials for reexamination and reevaluation - points to keep in mind in planning and implementation
- Characteristics of electronic certificates used in application electronic data systems (March 2022)
- Internal process flow when utilizing the registry for drug approval applications, etc. (from internal proposal to registry modification) (December 2022)
- Slide presentation "Current status and issues of post-marketing surveillance, etc. in Japan - GPSP questionnaire survey" (July 5, 2025, 27th Annual Meeting and Conference of the Japanese Society for Drug Information)
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3. surveillance/periodic report/post-marketing surveillance
The Green Book and other guidance documents may not reflect the latest notifications, etc. Please be sure to check the publication date.
Please be sure to check the publication date, and if necessary, refer to the original text of the notices, etc. at the following sites.
- Unknown Non-Serious Periodic Reporting (Guidance for Preparation of Electronic Adverse Reaction and Infectious Drug Reaction Case Reports -E2B(R3)- (2022 Edition, Commentary)
- Guidance for Periodic Safety Reporting - Gateway System Use - (May 2024)
- Guidance for Preparation of "Post-marketing Surveillance Implementation Plan" and "Post-marketing Surveillance Implementation Report" (revised edition of 2024)
- Guidance for Preparation of "Periodic Report of Infectious Diseases" (2025 Revision)
Click here for past history
Click here for past history
Not applicable.
Click here for past history
4. adverse reaction report
The Green Book and other guidance documents may not reflect the latest notifications, etc. Please be sure to check the publication date.
Please be sure to check the publication date, and if necessary, refer to the original text of the notices, etc. at the following sites.
- Guidance for Preparation of Failure Reports Related to Combination Products as Medicinal Products (2025 edition)
- Guidance for Preparation of Electronic Adverse Reaction and Infectious Drug Reaction Reports, etc. -E2B(R3)- (2022 Edition) Including Periodic Reporting of Unknown and Non-Serious Adverse Reactions and Clinical Trial Annual Report
Click here for past history
- Education and training materials for E2B(R3) commentary (April 2024)
- Electronic Model] Electronic Detailed Questionnaire for Adverse Event Surveillance (Pharmaceutical Cooperative Electronic Model (PDF)) (February 2024)
- [Paper model] Detailed investigation form used in adverse event investigations (Pharmaceutical Cooperative Association of Japan electronic model (PDF)) (February 2024) [Paper model] Safety information communication form to medical institutions conducting clinical trials (April 2022)
- [Paper model] Detailed Questionnaire for Adverse Reaction Surveillance (Pharmaceutical Cooperative Association of Japan model (paper)) (February 2012)
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Not applicable.
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Provision of information (electronic letter, IF, etc.) 6.
The Green Book and other guidance documents may not reflect the latest notifications, etc. Please be sure to check the publication date.
Please be sure to check the publication date, and if necessary, refer to the original text of the notices, etc. at the following sites.
- Guidance for preparation of "electronic package inserts for ethical drugs" (revised version as of April 2024)
- Guidance for Notification of "Electronic Drug Information Sheet for Prescription Drugs" (revised August 2023)
- Guidance for providing information on "electronic package inserts of ethical drugs" (revised version as of February 2024)
- Guidance for Creating Electronic Files of Attachment Information for Ethical Drugs - XML format - Provisional Version 1
- Guidance for Preparation of Interview Forms for Drugs (Revised May 2020: Provisional Version)
Click here for past history
Click here for past history
Click here for past history
DX-related (electronic provision of information, etc.) 7.
The Green Book and other guidance documents may not reflect the latest notifications, etc. Please be sure to check the publication date.
Please be sure to check the publication date, and if necessary, refer to the original text of the notices, etc. at the following sites.
For information on electronic subscriptions and IFs, please refer to 5.
Not applicable.
Questionnaire Results (General)
Questionnaire results (information provision for healthcare professionals)
Questionnaire Results (Information for Patients)
- Survey on Access to Drug Information for Patients and Families - Preliminary Report - (Conducted February 2024)
- Results of a survey on the provision of information to patients using digital technology (companies participating in the PV Subcommittee - conducted January-February 2023)
- Report on "Survey on Sei-katsu-sha Attitudes toward Drugs and the Pharmaceutical Industry" Public Relations Committee
- Report on Survey of Patient Organizations (Committee for Promotion of Patient Organization Collaboration)
- Survey on the problems of patients with rare diseases Industrial Policy Committee (conducted February 2023)
- Issues and Causes Analysis of Health Communication between Patients/Citizens and Pharmaceutical Companies DS Subcommittee (June 2024)
- Slide presentation "From the Pharmaceutical Industry - "How do you want us to utilize? Thoughts on various materials" (November 1, 2025, 19th Annual Meeting of the Japanese Society of Pharmacy)
- Shaping the Thoughts of Pharmaceutical Companies: The Challenge of Delivering Appropriate Drug Information to Patients (October 13, 2025, 58th Annual Meeting of the Japanese Pharmacists Association) Lecture slides
- Providing Information on Adverse Reactions: How to Provide Information for the Next Generation Lecture slides from the 16th Annual Meeting of the Japanese Society of Pharmaceutical Medicine, July 25, 2025
- Delivering the Latest Information Patients Need - From a Pharmaceutical Company's Perspective - July 6, 2025, Drug Information Society of Japan, Lecture Slides
Post-marketing surveillance, etc.
The Green Book and other guidance documents may not reflect the latest notifications, etc. Please be sure to check the publication date.
Please be sure to check the publication date, and if necessary, refer to the original text of the notices, etc. at the following sites.
- Guidance for Conducting Post-Marketing Database Surveillance -November 2025 Edition- (November 2025)
- Guidance on Procedures for Lifting Conditions of Approval for Post-Marketing Surveillance, etc. / Explanation of "Q&A on Use-results Surveillance of Ethical Drugs by the All Patient Surveillance Method" (October 2024)
- Guidance for Periodic Safety Reporting - Gateway System Use - (May 2024)
Click here for past history
- How to proceed with post-marketing database survey studies using the registry - February 2025 edition - (March 2025)
- Examination of Issues for Ensuring Reliability for Post-Marketing Database Surveillance (June 2022)
- Toward the Study of Establishing a Safety Surveillance Plan in accordance with "How to Proceed with the Study of Establishing a Plan for Conducting Post-Marketing Surveillance, etc. of Pharmaceuticals" (May 2020)
- Collection of Examples of Post-Marketing Database Survey Implementation Plans (August 2018)
Post-marketing surveillance, etc.
The Green Book and other guidance documents may not reflect the latest notifications, etc. Please be sure to check the publication date.
Please be sure to check the publication date, and if necessary, refer to the original text of the notices, etc. at the following sites.
Not applicable.
Not applicable.