Drug Evaluation Committee Guidance for providing information on "electronic package inserts for ethical drugs May 2021 edition
May 2021
In order to ensure the efficacy and safety of pharmaceutical products, manufacturers and distributors have made efforts to provide information on the proper use of pharmaceutical products to medical professionals in a prompt and accurate manner. With the rapid development of information technology in recent years, the provision of information has come to be carried out using a variety of tools.
The revised Pharmaceutical Affairs Law will come into effect on August 1, 2021, and the electronic package inserts will become the standard, and after a transitional period, the package inserts will no longer be included with products. In this context, in addition to the conventional provision of information, there is a demand for the development of a system and procedures for the provision of information, including the provision of information to new purchasers, etc. We have prepared a revised version of this guide.
In light of the various ways of working, including telecommuting, that have been introduced over the past year, and in response to requests for the Green Book to be made available online, we have made the revised version available online instead of in a booklet format.
We hope that this guide will be of use in providing appropriate information, including new responses, to pharmaceutical professionals.
Drug Evaluation Committee PV Subcommittee Task Force 1 (TF1)
Guide to Providing Information on Electronic Drug Information Sheets for Prescription Drugs (2.3MB)