On 25 December 2023, Japan waived the requirement for domestic phase I clinical trials of drugs developed overseas before Japanese individuals participate in international phase III trials for pharmaceutical regulatory approval. This policy change aims to address Japan’s ‘drug lag’. For example, in 2020, 72% of drugs approved in the United States and the European Union still awaited approval in Japan.
Competing Interests
Table of Contents
A.O. received personal fees from Medical Network Systems Inc. and Kyowa Kirin Co. Ltd outside the submitted work. T.T. received personal fees from Medical Network Systems Inc. and Bionics Co. Ltd, outside the submitted work.