In response to the growing threat of counterfeit pharmaceuticals, at Daiichi Sankyo, we are reviewing the sealing materials used in the products we manufacture and market, and working on changing their package specifications. We are also working to evaluate and introduce technologies to prevent counterfeit pharmaceuticals from being marketed.
In order to enhance the traceability of pharmaceutical products, the labelling of GS1 codes will become obligatory by 2021, and pharmaceutical companies in Japan will be required to display the codes incorporating data on expiration dates and manufacturing numbers on the sales package unit and the tertiary package unit. Daiichi Sankyo is responding to this obligation, and GS1 codes are now being used for more than 90% of our products. They will be used on all products by 2021. Going forward, we will cooperate with the pharmaceutical industry and related bodies to consider what roles are required of a marketing authorization holder, as well as enhance measures for responding to risks.
In European countries, the United States, and other countries where serialization*1 is also becoming a requirement, we are taking steps to reliably address this in each individual country. Within the United States in particular, we are already responding to serialization requirements based on the Drug Supply Chain Security Act (DSCSA), and we have also completed serialization at sales unit and packaging level.
In addition, we are actively promoting compliance with the GDP*2 to increase the assurance of reliability during the storage and transportation of pharmaceuticals. Moreover, Daiichi Sankyo is a member of Rx-360, a consortium of global pharmaceutical companies and suppliers. The purpose of the consortium is to introduce a global quality assurance system and audit program to prevent counterfeiting. We are also striving to precisely respond in accordance with the regulations and risks in all countries and regions where we operate, in order to combat the global issue of counterfeit pharmaceuticals and are engaging in diligent study to ensure we can safely deliver pharmaceuticals to patients.
- *1The assigning of a unique serial number to each sales packaging unit for product logistics management (tracking and tracing)
- *2Good Distribution Practice.