Rohto Pharmaceutical Co., Ltd., as a company that delivers a wide range of products to customers, including over-the-counter (OTC) medicines, cosmetics, and food products, complies with regulations applicable to each product category, such as the Pharmaceuticals and Medical Devices Act, the GVP Ministerial Ordinance *, and the Food Sanitation Act.
Specifically, we comprehensively review all information received from customers, patients, medical institutions, pharmacies, etc., as well as information from academic societies and overseas sources, to evaluate daily whether there are any safety issues with our products and whether they are being used correctly. If we determine that a warning is necessary regarding safety or usage, we review and strengthen the content of our labeling and information provision, and strive to disclose appropriate information. Furthermore, in order to identify safety-related issues with greater accuracy from the initial stages and respond quickly, we incorporate the opinions of specialists and have established a system to further ensure the safety of our customers and patients. In addition, in the pharmaceutical field, we actively participate in safety initiatives of industry associations related to our products and contribute to improving industry standards. We will continue to strengthen our efforts to ensure safety in the future.
*GVP (Good Vigilance Practice) Ordinance: Ordinance for the proper implementation of safety management operations related to pharmaceuticals, etc.
For safe use of the product
- Safety information collection and verification
Management and storage of safety information
We meticulously manage all information regarding health problems received from customers, patients, and medical professionals, conduct detailed investigations as needed, and store the information in our safety database.
We also check medical literature and information on measures taken by overseas regulatory authorities on a daily basis.
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.
*In the box
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