Initiatives to Publish Review Concepts through Early Consideration of Pharmaceuticals and Medical Devices Agency (PMDA)

Abstract

 In recent years, there has been concern about the increase in “drug loss” : drugs that are approved in Europe and the United States but are not developed in Japan. Factors contributing to this include a lack of understanding of Japan’s drug discovery environment and pharmaceutical affairs system. Meanwhile, in Europe and the US, guidance and concept papers on the development of drugs using innovative technologies are published early on, leading to exchanges of opinions with industry and the promotion of development. In the Fifth Medium-Term Plan, the Pharmaceuticals and Medical Devices Agency (PMDA) advocates the implementation of consultations and reviews that accurately respond to innovation, such as dissemination of Early Consideration and development of clinical evaluation guidelines based on the latest scientific knowledge. Early Consideration is a reference information for practical application of innovation and promotion of development of innovative drugs, although it is at the stage where information is not collected sufficiently. It shows the view of the reviewers regarding the direction of development at that time. The aim is to provide consultation services and approval reviews for new pharmaceuticals that appropriately respond to innovation by compiling and publishing Early Consideration on issues such as the practical application of innovative technologies and the development and evaluation of pharmaceuticals, and by formulating new clinical evaluation guidelines and revising existing ones based on the latest scientific knowledge. This article introduces the background and outline of eight Early Consideration documents published by the PMDA by January 2025.