While pharmaceuticals are useful for treatment, they may adversely affect health, for example, due to side effects. For this reason, manufacturers of pharmaceuticals and medical devices in Japan, including Santen, are required by law to report cases of suspected adverse events to the Ministry of Health, Labour and Welfare (MHLW).
Santen has established and documented internal procedures to be taken when we receive information relating to safety, including adverse event information, from patients or healthcare professionals. The procedures require us to report the information immediately and appropriately to our department of safety management, to enable the information to be shared among related departments within the company. Based on the procedures, we have built a globally effective reliability assurance system, desirable also from the perspective of pharmacovigilance. We think it is crucial for all of our officers and employees to understand our responsibilities and the actions we should take, so we provide them with adequate training.
Click on the following link to find out more about our Global Quality Compliance.
- Quality Compliance