Product Quality & Safety

Santen ensures the quality and safety of its products and has an established system for providing products whenever they are needed, to allow patients to use Santen products and services with a feeling of security and trust.

Assurance of Product Life-Cycle Reliability

Quality Principle Policy

Santen will contribute to the well-being of society by achieving happy lives through vision around the world, by taking advantage of technology necessary to ensure high quality and safety for products and services which meet the applicable laws, regulations, specifications as well as standards of quality.

The Company seeks to assure the reliability of the product life-cycles of pharmaceuticals according to our "Quality Principle Policy."

All Santen employees working for production and quality control receive education, on appointment and regularly, on quality control, standard operating procedures (SOP), and other topics useful for maintaining product quality and reliability.

Quality Assurance Division to supervise quality assurance, safety vigilance and auditing with the aim of promoting compliance activities in order to assure corporate compliance including product quality, safety and post marketing responses. Click on the following link to find out more about our assurance of product life cycle reliability.

Quality Compliance

Measures against Counterfeit Medicines

Santen is working on global supply chain security measures as well as responding to Good Distribution Practice (GDP) in order to protect patients from problems such as health hazards and worsening of medical conditions due to loss of treatment opportunities due to the distribution of counterfeit medicines. We ensure the integrity of our products and operate a lot trace system by implementing features to prevent unauthorized opening of containers and boxes for our products. Also, we are working to strengthen product traceability(*1) by responding to serialization(*2) in accordance with local regulations. In addition, in order to ensure the integrity of legitimate distribution channels, we consider local regulations regarding distribution, assesse the risk of distribution channels, evaluate distributors through audits, enter into quality contracts, and monitor defect events.

  1. Traceability: To be able to track and understand the distribution route from medicine manufacturing to consumption.
  2. Serialization: Assessing a unique identification code to a product to control distribution from manufacturing to consumption of the medicine

Efforts to Obtain Information Relating to the Safety of Pharmaceuticals

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

Product Recall

If any issues are found regarding the safety, efficacy, quality, labeling or other respects of our products, Santen immediately reports such issues to the authorities, provide the information to medical institutions, and recall applicable products based on our quality assurance system. The number of voluntary product recall in the past four years are as follows and no health hazards related to these recalls were reported.

Number of voluntary recallsFY2019FY2020FY2021FY2022
Class Ⅰ(*1)0000
Class Ⅱ(*2)301
  1. Class Ⅰ: Situations where the use of the product can cause serious health damage or death
  2. Class Ⅱ: Situations where the use of the product may cause temporary or medically curable health hazards, or the risk of serious health hazards is unlikely.

Prevention of Medical Mistakes

Drug errors may not only prevent patients on such drugs from obtaining the anticipated effect but may also cause the onset of unanticipated side effects. To prevent such medical mistakes, Santen provides clearly identifiable packaging and information labels on containers, in an effort to reduce the workload of medical staff required to identify drugs, as well as to ensure accuracy in handling drugs.

For example, for eye drops available in various concentrations with the same components, we provide information on the concentration on the shrink labels that cover the eye drop containers as well as at the top of the cap in different colors.

Examples of eye drop containers