Drug Evaluation Committee Education and Training Materials for E2B(R3) Explanation
Electronic Information Subcommittee
April 2024
In Japan, reporting by ICH E2B(R3) to the Pharmaceuticals and Medical Devices Agency has become mandatory as of April 1, 2019. For smooth handling of adverse drug reaction reports, the Committee on Drug Evaluation of the Japan Pharmaceutical Manufacturers Association (JPMA) has published the "Guidance for Electronic Reporting of Adverse Reactions and Infectious Drug Reactions" (latest edition*: issued in September 2022). In actual training, I am sure that the training materials are prepared in accordance with the experience and knowledge of the target audience. To help pharmaceutical companies implement education and training more efficiently and appropriately, and to reduce the burden on education and training staff in charge of creating training materials, the Electronic Information System Subcommittee TF2-1 has created the Education and Training Materials.
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As of December 2023Items related to side effects of control drugs and concomitant drugs used in addition to the study drug have been added in accordance with the revision of the Pharmaceutical Affairs Law enforced in September 2020. Details of the updated contents are listed on the last page of each material.
Published March 2020
Revised April 2024*
Notes on Use
- The information in this material is based on current information. Please note that future trends may change the situation.
- PDF files (originals created by the Digitization Information Subcommittee) may not be altered.
- PPT files may be modified and used as appropriate at the responsibility of each company, but we cannot be held responsible for the content after modification.
E2B(R3) Explanation - Introduction
Materials designed to provide an overview of E2B(R3) and prepare those who will engage in adverse drug reaction reporting for the first time under E2B(R3) or those who wish to review E2B as they transition to E2B(R3) in order to understand the details of the new system.
| File | Hash value (*) (MD5) |
|---|---|
| Download (1.4MB) (slides only) | a64917e4226295c8446f2b5475621004 |
| Download (1.3MB) (with notes) | 674bb6fd48265de090e15d17d50fd524 |
| Download (1.4MB) (with notes) | 0c0c8197f941a80b236e9646c50e1c1b |
E2B(R3) Explanation-Practical Use
Materials for those who have knowledge of E2B(R2) and those who were engaged in electronic reporting of adverse drug reactions under E2B(R2) to understand the changes from E2B(R2) and the details of E2B(R3).
| File | Hash value (*) (MD5) |
|---|---|
| Download (1.3MB) (slides only) | b330ae15b8399a0aa24c0970b369bcdd |
| Download (1.3MB) (with notes) | 41a5e45b6e328cba9f8b42b0beec6790 |
| Download (1.2MB) | 15d6660fc65555ad8db7d10100762220 |
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As of December 2023Files with hash values different from the above indicate that they have been modified from the original.
Deliverables of the Drug Evaluation Committee Return to list of all deliverables