Collection and accumulation of safety information
We collect all information about adverse health effects received from customers, patients, medical professionals, and others, conduct detailed investigations as necessary, and store the information in a safety database.
We also regularly check medical literature and information on measures taken by overseas regulatory authorities.
Data evaluation and analysis
The collected information on health damage, etc. is evaluated for severity, novelty, causality, etc. for each case, and the information accumulated in the database is regularly analyzed to check for any changes in occurrence trends or severity.
Consideration of safety measures
If, as a result of the evaluation and analysis, we determine that there is a possibility of an increase in health hazards, such as abnormal findings such as a significant increase in the number of reports, we will consider necessary measures to minimize the harm to customers and patients.
Decision on response measures
We consider the seriousness and urgency of the problem and, in consultation with regulatory authorities, determine the best safety measures to prevent harm to customers and patients. We also regularly report to the government as required by law and strive to share information with regulatory authorities.
Information provision/information disclosure
In order to properly implement safety measures that have been decided upon to prevent the spread of health hazards, we will prepare notices and other materials as necessary to customers, patients, and medical professionals, and provide information by distributing them directly and posting them on the Pharmaceuticals and Medical Devices Agency and our website.
Towards proper use
Our goal is to ensure that Rohto products are used safely and effectively by collecting, evaluating, and providing information on health hazards.