Drug Evaluation Committee Guidance for Preparation of Explanation of "Precautions" for New Drugs
March 2019
Task Force 3 of the PV Subcommittee of the Drug Evaluation Committee has prepared a "Guide for Preparation of Explanation of 'Precautions for Use' for New Drugs" in response to the new guideline for the description in the package insert of ethical drugs, in cooperation with the Drug Safety Measures Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labor and Welfare, and Drug Safety Measures Department 1 and 2, PMDA.
This guide is intended for new pharmaceutical products approved on or after April 1, 2019, for which the package insert has been prepared in accordance with the new instructions for package inserts.
This guide will be revised at an appropriate time after April 2019, when we have accumulated more examples of products with new instructions for use in the package inserts.