Résumé
The pharmaceutical regulatory system of Japan and its evolution were strongly influenced by the country’s history. This system, opaque, complex, and difficult to understand for “non-Japanese” entities slowly discouraged multinational companies to invest and develop medicines in Japan; resulting in drugs not registered in Japan at all or with a consequent delay compared to other regions like Europe or US (“drug lag”). The drug lag consequently became a public health issue in Japan. The crucial need for a better evaluation system of new medicines led to the reorganization of Japanese health authorities which and to deep modifications of the pharmaceutical regulation. Measures were also taken to streamline the development and the registration of new medicines. They encourage the early inclusion of Japan in development plans thanks to the setup of an early and regular dialogue with the PMDA via the consultation system all along the development of the product until the marketing authorization application. The implementation of ICH guidelines and the harmonization of marketing authorization dossiers format among different regions are also part of the measures taken to streamline the registration of new medicines in Japan. The setup of all those measures allowed Japan to catch up with the so-called drug lag and to reach one of the fastest evaluation timelines worldwide among stringent regulatory authorities.