Japan May Require Drugmakers to Conduct Postmarketing Surveys in Some Cases

Drugmakers seeking a marketing authorization in Japan may be required to conduct postmarketing surveys of patients who use their products, the Pharmaceutical and Medical Devices Agency (PMDA) says. The surveys would be required as a condition of approval when the application is based on data from few or no clinical trials conducted in Japan, the PMDA says in a question-and-answer document posted on its website recently.
International Pharmaceutical Regulatory Monitor