A Review of the Regulatory Process in Japan

Abstract

In Japan, all the preclinical (mainly animal) and clinical data on drugs are evaluated for their clinical efficacy and safety when an application is made to the Minister of Health and Welfare for their license and marketing. After the approval has been given, the drugs are treated differently depending on whether or not they are new. In cases where the drugs are new (e.g., containing new chemical entities), they have to undergo re-examination 6 years (in principle) after the first approval on the basis of postmarketing information on efficacy and safety. Drugs which are not new undergo re-evaluation every 6 years in order to check their efficacy and safety, although the priority of re-evaluation is given to each drug or group of drugs depending on its clinical importance. All drugs have to undergo ad hoc re-evaluation in the special cases where certain problems regarding their safety or efficacy arise.