Drug Evaluation Committee Regulatory Information Management System (RIMS) Implementation Guide
Electronic Standard for Medical Information Expert Committee
February 2018
Electronic Standard for Medical Information Expert Committee As part of its activities in fiscal 2016-2017, Task Force 3 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 Introducing a Regulatory Information Management System (RIMS)". This guide is based on the results of the above survey.
In addition to the results of the survey, this guide also provides Explanation of the trends in pharmaceutical regulations surrounding RIMS, the current status and issues faced by pharmaceutical companies, and key points to consider when introducing a 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)