The Japan – New Drug Application (J-NDA) is the Japanese equivalent of the New Drug Application (NDA) in the USA or the Marketing Authorisation Application (MAA) in Europe. It is the formal application submitted to the Japanese regulatory authority, the Pharmaceuticals and Medical Devices Agency (PMDA), to obtain approval for a new drug on the Japanese market. The Japanese market is one of the largest in the world, making the J-NDA a critical milestone in global drug development.
Although the PMDA closely follows international standards such as the ICH guidelines, there are specific local requirements that must be taken into account. These often include requirements for conducting clinical trials with Japanese patients to investigate ethnic differences in pharmacokinetics or efficacy (‘bridging studies’). For globally operating CROs, it is therefore essential to have specific expertise in Japan’s regulatory requirements in order to support sponsors in the successful submission of a J-NDA and market entry in Japan.