At a very high level, the process for drug registration in Japan involves the submission of extensive documentation, including preclinical and clinical data, to the Pharmaceuticals and Medical Devices Agency (PMDA). PMDA evaluates the safety and efficacy of the drug, and if approved, the Ministry of Health, Labour and Welfare (MHLW) grants marketing authorization. The full process is more complex and requires further reading than what’s available in this FAQ.
