Drug Evaluation Committee Guidance for Preparation of the Drug Interview Form (Revised Version)
Pharmacovigilance Subcommittee
May 2020
The Pharmacovigilance (PV) Subcommittee of the Drug Evaluation Committee, Team 4 for Ongoing Issues has prepared the "Guidance for Preparation of the Drug Interview Form (Revised Version)", revised in May 2020 (tentative version). This guide corresponds to the Guideline for Drug Interview Form 2018 (updated version in 2019) (see https://www.jshp.or.jp/cont/19/1226-4.html) established by the Japan Hospital Pharmaceutical Association (JHPMA).
In September 2018, the Ministry of Health, Labour and Welfare (MHLW) issued the "Guidelines for Sales Information Provision Activities of Ethical Drugs" with the aim of improving health and hygiene by ensuring the appropriateness of advertisements or similar activities conducted by pharmaceutical companies and others in their sales information provision activities. Subsequently, a Q&A was issued (in 2028) stating that it is acceptable to provide information on the stability of a drug when it has been subjected to simplified suspension, crushing, etc., which are not permitted under the approval, by including such information in an interview form, and organizing such information as requested by a medical professional in accordance with the Guidelines. This guide has been revised in accordance with the Q&A issued in September 2048 (Office Communication).
The preparation of interview forms based on the Guideline for the Description of Interview Form 2018 is applicable to drugs with new active ingredients, changes in indications, dosage and administration, and new routes of administration approved in April 2019 or later, but if the interview form is prepared or revised in October 2020 or later, the interview form must be prepared in accordance with the Guideline for the Description of Interview Form 2018 (updated in 2019). However, if the interview form is created or revised after October 2020, it must be in accordance with the Interview Form Guideline 2018 (updated version in 2019).
The Interview Form is being reviewed by the Interviewee Form Review Committee established by JCIA (see https://www.jshp.or.jp/cont/22/1212-1.html) to confirm that it is in compliance with the Guideline and the Guidance for Preparation and that it contributes to the proper use of the drug. This document is being used as a guide for interview forms to be used by each member company.
We hope that this document will be of assistance in the preparation of interview forms by our member companies.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Pharmacovigilance Subcommittee, Continuing Issues Response Team 4
Guidance for Preparation of IF_Revised in 2020 (2MB)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables