Home » Japan May Require Drugmakers to Conduct Postmarketing Surveys in Some Cases
Japan May Require Drugmakers to Conduct Postmarketing Surveys in Some Cases
November 16, 2009
Drugmakers seeking a marketing authorization in Japan may be required to conduct postmarketing surveys of patients who use their products if the country’s
Pharmaceutical and Medical Devices Agency (PMDA) decides the evidence supporting a drug’s approval leads to the requirement, the agency says. Includes the full text of Japan PMDA Q&A on Postmarketing Surveys.
To View This Article:
Subscribe To International Pharmaceutical Regulatory Monitor