Drug Evaluation Committee Search by E-Book
Please refer to the PV-related Green Book and other publications from this page.
- List of all deliverables
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(New arrivals first)
- Publication of "Hands-on Workshop on Utilization of Medical Information Databases in PV Activities (Held in September 2025) Video of Dr. Chieko Ishiguro's Lecture "Possibility of Utilization of Medical Databases in Regular Safety Monitoring Activities"" (February 2026) (February 2026)
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Results of Questionnaire on Information Provision Activities at the Time of "Precautions for Use" Revision
-Trend of each company after the revision of the "KENSENSHU GUIDELINES" (December, 2025) (December 2025) - A Review of the First 10 Years since the Introduction of the RMP System from the Pharmaceutical Industry's Perspective (December 2025)
- Guidance for Conformity Surveillance for Reexamination, etc. (October 2025)
- Tips for Signal Management Activities in Japan (August 2025)
- Guidance on the Preparation of Defect Reports for Drug Combination Products (2025 Edition) (July 2025) (in Japanese) (July 2025)
- Guidance for Preparation of a Drug Risk Management Plan (J-RMP) -January 2025 Edition- (January 2025) (January 2025)
- Explanation of Procedural Guidance 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"-Gateway System Use (May 2024) (May 2024)
- Guidance for Remote Investigation (Reexamination) Ver3.0 (March 2024) (April 2024) (April 2024)
- Guidance for Preparation of "Electronic Attachments of Ethical Drugs" (Revised version, April 2024) (April 2024)
- Guidance for Reexamination Application -Gateway System Use- (March 2024) (March 2024)
- Guidance for Preparation of "Post-marketing Surveillance Implementation Plan" and "Post-marketing Surveillance Implementation Report" (Revised edition, March 2024) (March 2024)
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Guidance for providing information on "electronic package inserts of ethical drugs" (February 2024 edition)
(February 2024) - Guidance for Conducting Post-Marketing Database Surveys -January 2024 Edition- (January 2024) (January 2024)
- Guidance for Conformity Surveys for Reexamination, etc. (December 2023)
- Guidance for Notification of "Electronic Attachment of Ethical Drugs" (August 2023) (August 2023)
- Guidance for Preparation of a Drug Risk Management Plan (J-RMP) -January 2023 Edition- (January 2023) (January 2023)
- Guidance for Preparation of "Post-marketing Surveillance Protocol" and "Post-marketing Surveillance Report" (revised edition, 2022) (December 2022) (December 2022)
- Guidance for Electronic Reporting of Adverse Reactions and Infectious Drug Reactions -E2B(R3)- (Explanation, 2022 Edition) (September 2022) (September 2022)
- Guidance for Remote Investigation (Reexamination) (May 2023) (May 2023)
- Guidance for Reexamination Application (October 2021)
- Guidance for Periodic Safety Reporting (September 2021)
- Guidance for Preparation of Defect Reports Related to Combination Products that are Medicinal Products (2021 Edition) (June 2021)
- Guidance for Creating XML Files for Clinical Trial Notification (4th Edition) (February 2021) (February 2021)
- Guide to the Creation of Electronic Files of Attachment Information for Ethical Drugs - XML Format - Tentative 1st edition published. (May 2019)
- Guidance for Creating Electronic Common Technical Documents (eCTD) (Part 1, Revised) (April 2017)
- Guide to the Preparation of Electronic Common Technical Documents (eCTD) (Part 3, Revised Edition) (April 2017)
- Guide to Creating Electronic Common Technical Documents (eCTD) (Part 4, Revised) (October 2016)
- Guide to eCTD Preparation, Edition 4.2 Gateway-compliant Edition (August 2016)
Please purchase from the JAPIC book sales site for FY2020 and earlier.
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