Japan’s Entry into Global Drug Development

Until the advent of ICH, Japan’s lack of alignment with US and EU medical practice and regulatory policy complicated the integration of drug development and delayed Japanese product approvals. However, after decades of continuous harmonization of medical practices and with the successful initiative of MHLW to create a regulatory framework aligned with the US and EU, integration of Japan and Asia into global drug development has become the norm and obtaining near simultaneous regulatory approval of products with FDA, EMA and PMDA is now feasible.

Japan as a Center for Global Drug Development

After years of steady regulatory reform that made Japan’s integration into US and EU led drug development programs possible, MHLW and PMDA have now brought forth dynamic initiatives aimed at establishing Japan as a global leader in the development of breakthrough drugs addressing high, unmet medical needs. Leveraging its multi-disciplinary team of drug development experts, IDA can not only successfully integrate Japan into global drug development programs but also work with clients to navigate these novel regulatory pathways established by MHLW and PMDA.

© 2016 IDA Integrated Development Associates.