Drug Evaluation Committee Search by E-Book
Please refer to this page for PV-related Green Book, etc.
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(New Arrivals Order)
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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 "KENSHU-AN" guidelines (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)
- Guidance on Procedures for Lifting Conditions of Approval for Post-Marketing Surveillance, etc. / Commentary on "Q&A on Investigations of Usage Results for 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 Attachments 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)- (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 JAPIC book sales site for those before FY2020.
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