PRECAUTIONS in package inserts include information such as Warning, Contraindications, Important Precautions, and Clinically Significant Adverse Reactions. When a new risk is identified, the Pharmaceuticals and Medical Devices Agency (PMDA) thoroughly investigates the risk and discusses a necessity of revision of PRECAUSIONS with expert advisors so that the PMDA can recommend an additional safety measure to the Ministry of Health, Labour and Welfare (MHLW). Following the investigation results from the PMDA, the MHLW issues a notice to revise PRECAUSIONS. Marketing authorization holders consequently revise PRECAUTIONS according to the notice.
Therefore, Detailed information on revisions of PRECAUTIONS is issued by the MHLW, and Summary of evaluation result is provided by the PMDA.