Drug Evaluation Committee Regulatory Information Management System (RIMS) Implementation Guidance
Electronic Information Subcommittee
February 2018
As part of its activities in fiscal 2016-2017, Task Force 3 of the Electronic Information Subcommittee conducted a survey on the status of RIMS introduction in Japan and a survey on RIMS products currently being handled in Japan, and has now prepared and published the "Guide to the Introduction of Regulatory Information Management Systems (RIMS) This guide is based on the results of the above survey and is available to the public.
In addition to the results of the survey, this guide explains the trends in pharmaceutical regulations surrounding RIMS, the current status and issues faced by pharmaceutical companies, and key points to consider when introducing RIMS. We hope that this guide will be of help to companies that are planning to introduce RIMS in the future.
Regulatory Information Management System (RIMS) Implementation Guide (880KB)
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