JPMA 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 notice, etc. at the following sites.
- *The Green Book is a guide prepared by the JPMA based on notifications and other information for each type of work, the contents of which are discussed with the regulatory authorities. Various PV-related guidelines other than the Green Book are referred to as White Books.
- *Documents that cover multiple categories are listed in duplicate.
(e.g., "Guidance for Preparation of Electronic Adverse Reaction and Infectious Drug Reaction and Infection Case Reports, etc." is included in both
"3. Accumulation Evaluation and Periodic Reporting/Postmarketing Surveillance" and "4. Adverse Reaction Reporting" because it includes contents of unknown and non-serious adverse reaction reports in addition to adverse reaction reports)
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 notice, etc. at the following sites.
Click here to see the past history
- JPMA website】PV：KT1 RMP training slides for MRs (revised August 2025)
- JPMA Website】PV：KT1 RMP/RMP Materials Utilization Case Studies - Mainly for Dispensing Pharmacies
- RMP Follow-up Survey (1st interim results)
- Explanation of the RMP Mark (Revised 2024) - For identification of materials based on additional risk minimization activities
- Comparative study of the status of development of additional risk minimization activities in RMPs 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
- Hands-on Workshop on Medical Information Database Utilization in PV Activities (held in September 2025) Dr. Chieko Ishiguro's lecture movie "Possibility of Medical Database Utilization in Normal Safety Surveillance Activities" will be available.
- A review of the first 10 years since the introduction of the RMP system from the perspective of the pharmaceutical industry
- Slides of the presentation "Collection of Case Studies of Utilization of RMP/RMP Materials" (19th Annual Meeting of the Japanese Society of Pharmacognosy)
- Slide "Efforts of the Pharmaceutical Industry to Promote Utilization of RMP/RMP Materials" (July 5, 2025, 27th Annual Meeting of the Japanese Society for Drug Informatics)
- RMP (including the latest information on the revision of reimbursement) Slides from the November 3, 2024 presentation at the Japanese Society of Pharmaceutical Science and Technology
Click here to see the past history
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 notice, etc. at the following sites.
- Guidance for Periodic Safety Reporting - Using the Gateway System (May 2024)
- Guidance for Application for Reexamination - Gateway System Use ver. 2.0 (March 2024)
- Guidance for Conformity Surveillance 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)
- Explanation of "Procedural Guide for Lifting Conditions of Approval for Post-Marketing Surveillance, etc. / Q&A on Investigation of Usage Results of Ethical Drugs Using the All Patient Surveillance Method" (October 2024)
Click here for past history
Click here for past history
- Impact of the Notification related to the "Study Group on the Drug Regulations to Enhance Drug Discovery Capability and Ensure Stable Supply, etc.," as revealed through the results of a survey in the pharmaceutical industry (December 2025, Pharmaceuticals and Medical Devices Regulatory Science)
- Leaflet "Do you know about the Pharmaceutical Company's Outcomes Surveillance?
- Post-marketing clinical trials other than post-marketing clinical trials pertaining to reexamination and reevaluation - Points to be noted 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 Assembly and Annual Meeting of the Japanese Society for Drug Information)
Click here for past history
Integrated Assessment / Periodic Reporting / Post-marketing surveillance 5.
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 notice, etc. at the following sites.
- Periodic Reporting of Unknown Non-Serious Diseases (Guidance for Preparation of Electronic Adverse Reaction and Infectious Drug Reaction and Infection Case Reports -E2B(R3)- (2022 Edition, Explanation)
- Guidance for Periodic Safety Reporting - Using the Gateway System (May 2024)
- Guidance for Preparation of "Post-Marketing Surveillance Plan" and "Post-Marketing Surveillance Report" (revised edition of 2024)
- Guidance for Preparation of "Periodic Reporting of Infectious Diseases" (Revised edition for 2025)
Click here for past history
Click here for past history
Not applicable.
Click here for past history
4. adverse reaction reporting
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 notice, etc. at the following sites.
- Guidance for the Preparation of Defect Reports for Combination Products (2025 Edition)
- Guidance for preparation of electronic adverse drug reaction and infection case reports -E2B(R3)- (2022 Edition) (Including periodic reports of unknown and non-serious adverse drug reactions and annual reports of clinical trials)
Click here for past history
- Education and training materials for E2B(R3) Explanation (April 2024)
- Electronic Model] Electronic Detailed Questionnaire for Adverse Event Surveillance (JPMA Electronic Model (PDF)) (February 2024)
- JPMA Recommended Form for Communicating Safety Information to Medical Institutions Conducting Clinical Trials (April 2022)
- [Paper model] Detailed Questionnaire for Adverse Reaction Surveillance (JPMA model (paper)) (February 2012)
Click here for past history
Not applicable.
Click here for past history
5. information provision (electronic letter, IF, 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 notice, 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)
For past history, click here
For past history, click here
For past history, click here
DX-related (electronic provision of information, etc.) 8. other
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 notice, etc. at the following sites.
For information on electronic subscriptions and IF, please refer to 5.
Not applicable.
Questionnaire Results (General)
Questionnaire results (information provision for healthcare professionals)
Questionnaire Results (Information for Patients)
- Survey on Patients' and Families' Access to Drug Information -Preliminary Report- (Conducted in February 2024)
- Results of Questionnaire on the Use of Digital Technology to Provide Information to Patients (PV Subcommittee Participating Companies, January-February 2023)
- Report on the Survey of Sei-katsu-sha Attitudes Toward Drugs and the Pharmaceutical Industry Public Affairs Committee
- Report on Survey of Patient Organizations (Patient Cooperation Committee)
- Survey on the problems of patients with rare diseases Pharmaceutical Industrial Policy Committee (conducted in February 2023)
- Issues and Causes Analysis of Health Communication between Patients/Citizens and Pharmaceutical Companies DS Subcommittee (June 2024)
- From the pharmaceutical industry ~ "How do you want us to utilize?" Thoughts on various materials - Slide presentation at the 19th Annual Assembly of the Japanese Society of Pharmacy, November 1, 2025
- From the Pharmaceutical Industry - "How do you want us to use them?" Slide presentation at the 58th Annual Meeting of the Japanese Pharmacists Association, October 13, 2025
- 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
7. 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 notice, etc. at the following sites.
- Guidance for Conducting Post-Marketing Database Surveillance -November 2025 Edition- (November 2025)
- Explanation of "Procedural Guide for Lifting Conditions of Approval for Post-Marketing Surveillance, etc. / Q&A on Investigation of Usage Results of Ethical Drugs Using the All Patient Surveillance Method" (October 2024)
- Guidance for Periodic Safety Reporting - Using the Gateway System (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 Investigation Implementation Plans (August 2018)
- Hands-on Workshop on Medical Information Database Utilization in PV Activities (held in September 2025) Dr. Chieko Ishiguro's lecture movie "Possibility of Medical Database Utilization in Normal Safety Surveillance Activities" will be available.
- Post-marketing clinical trials other than post-marketing clinical trials pertaining to reexamination and reevaluation - Points to be noted in planning and implementation
DX-related (electronic information provision, etc.) 8. other
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 notice, etc. at the following sites.
Not applicable.
Not applicable.