Drug Evaluation Committee Report on the Information Meeting on the Detailed Questionnaire for Adverse Reaction Surveillance (JPMA electronic model)
Pharmacovigilance Subcommittee
Introduction
On November 13, 2025, the Pharmacovigilance Subcommittee (PV Subcommittee) of the Drug Evaluation Committee of the JPMA held a briefing session on "Detailed Questionnaire for Adverse Reaction Surveillance (JPMA Electronic Model) - Focusing on Sharing Case Studies -" via a web conference. This session was planned and managed by the PV Subcommittee's Continuing Issues Team 2 (KT2), and was attended by many members of the safety departments of PV Subcommittee member companies, especially those involved in adverse drug reaction case evaluation work.
The JPMA electronic model, which was released in February 2024, aims to reduce the burden on healthcare professionals in detailed adverse drug reaction investigations and to speed up and improve the quality of the process from information collection to evaluation by computerizing the process. The briefing session was opened by Mr. Matsumoto, KT2 sub-leader, who emphasized that the project aims to promote and facilitate the use of the electronic model.
Briefing session operation
Overview of the JPMA electronic model and results of the questionnaire regarding its introduction
In the first session, KT2 explained the background of the development of the JPMA electronic model, its features (input check function, locking function, etc.), and the expected benefits. The results of a questionnaire survey conducted by KT2 prior to the event were also shared, indicating that while many companies are considering the introduction of the JPMA electronic model, they feel that there are issues regarding the flow of information transfer with Investigator Sites and the method of resurvey. In particular, there was a great deal of interest in the case studies of other companies, which once again confirmed the intent of this briefing session.
Examples of introduction of the JPMA electronic model
Three companies that have already started using the JPMA electronic model (electronic survey form) took the stage to introduce their case studies.
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Mr. Nakamura, Tanabe Pharma Corporation (former Mitsubishi Tanabe Pharma Corporation)
A workflow was established in which MRs serve as intermediaries to guide physicians and collect electronic survey forms. As issues after the introduction of the system, they shared specific countermeasures, citing the problem of physicians opening PDF files on their browsers, which prevents the function from working properly, and the need to educate MRs to promote the use of the system.
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SHIONOGI & CO., LTD.
A collection workflow has been established in which MRs make requests to physicians and physicians directly upload the information to cloud storage, without involving MRs, to speed up the transfer of information. In order to address the issues identified in the pilot operation, the company enhanced the education for MRs and achieved a steady improvement in the digitization rate.
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Mr. Matsumoto, Astellas Pharma Inc.
Based on the issues with the conventional paper-based system, an operational flow was established based on the transfer of information by e-mail. Based on the results of a survey of MRs after the introduction of the system, he explained the effects of improved response time and legibility, as well as future issues to be addressed, such as how to deal with facilities that are difficult to deal with electronically.
After each company's presentation, a lively Q&A session followed, providing participants with a valuable opportunity to compare their situation with that of their own companies and gain practical hints on how to solve problems.
Status of the safety database's compliance with the JPMA electronic model
The final session reported the results of a survey of major safety database vendors. Some have already implemented functions for importing data collected by the JPMA electronic model into their databases, while others are in the process of development, including the use of AI, indicating expectations for further streamlining of data entry operations in the future.
Concluding Remarks
Mr. Kawaguchi, KT2 leader, gave closing remarks, expressing his hope that the introduction of case studies would contribute to solving issues faced by each company and that the JPMA electronic model would spread to more companies.
In the questionnaire after the session, many positive comments were received, such as, "The specific efforts of other companies and how they dealt with issues were helpful," and "It gave me a concrete image of how to proceed with the implementation of the model in my company.
We hope that the sharing of case studies will help solve the issues faced by each company and promote the industry-wide DX initiative to computerize detailed surveys. All of us in the planning and management team are very happy to have been involved in solving the issues faced by the industry as a whole, including healthcare professionals.
Drug Evaluation Committee, Pharmacovigilance Subcommittee, Continuing Issues Team 2
In charge of running the briefing session: KT2 Leader Kawaguchi, Sub-leader Matsumoto, TeamB2 (Ogawa, Kashiwabara, Kosaka, Sakaguchi, Tai, Masamune (alphabetical order, titles omitted))