Safety Management ⁄
Quality Assurance
A System for Information Collection and Distribution for Greater Safety and Reliability
In order to promote more widespread use of generic drugs, we collect detailed information on the proper use of such drugs. By providing the latest information, we are encouraging widespread use of the generics that patients, medical institutions and insurance dispensing pharmacies trust.
Highly-experienced MRs provide the latest pharmaceutical information.
Medical representatives (MRs) have expert knowledge of fundamental information such as the package inserts, interview forms and product information summaries of generic drugs, as well as various additional information about the drugs. Our MRs, who are based in ten offices throughout the country, provide information accurately and promptly.
A System for Assuring Reliability and Providing Excellent Generic Drugs
The Reliability Assurance Department complies with the Pharmaceutical Affairs Law, GMP, GQP, GVP and other regulations in order to maintain high ethical standards and deliver excellent generic drugs to the market.
Safety is the key to the future of generic drugs
Pharmaceuticals are vital products that are directly related to human life and health.
For them to be used properly, it is important to reliably and quickly provide information on their efficacy, safety and quality to the doctors and pharmacists who are on the frontline of medicine.
As a generic drug company, we follow GVP* for the efficacy, safety, etc. of the products that are used in medical practice, collecting information on adverse events that healthcare professionals experience as well as journal articles, conference presentations, and research reports, which are thoroughly reviewed and investigated. As a safety countermeasure, this information is also provided to medical institutions and insurance dispensing pharmacies, encouraging the proper use of drugs.
*GVP: “Good Vigilance Practice”. Standards for post-marketing safety management of pharmaceuticals
Aiming to build a better quality assurance system
We practice strict quality assurance for our marketed generic drugs using “objective scientific evidence” and follow regulations such as the Pharmaceutical Affairs Law, the GQP* ministerial ordinance and the GMP ministerial ordinance. Of course, we always ensure the product quality from the patients' standpoint.
We also actively solicit the opinions and requests of patients to help us improve the reliability of our products.
*GQP: "Good Quality Practice" Standards for quality assurance in the manufacture and sale of pharmaceuticals.