“Specified Clinical Research” Data May Be Acceptable for Drug Registration in Japan

Normally, drug approval in Japan is based on clinical trials done under Japanese GCP requirements. On the other hand, clinical research not initially used for drug registration is called Specified Clinical Research (SCR). SCR is regulated by the Japanese Clinical Research law. Recently, the MHLW outlined that SCR can be used only when GCP-based clinical research is not available or difficult to perform. SCR may be used depending on the SCR results and if the data are stored and accurate – only on a case-by-case basis. Research investigators are responsible for assuring the SCR data are reliable and valid.

Recently, the MHLW funded a study looking into the use of SCR data for breast cancer (the Potent Study). In this study, the study group concluded that SCR data met the same standards as GCP clinical trial data. The study group advocated for the use of SCR data in cases of rare diseases or diseases that need care immediately where there is no time to do traditional GCP studies. To date, most SCR studies have been done in Japan in the cardio, cancer, and neuro areas.