Reliability Assurance

Reliability Assurance

We apply for governmental approval for new drug manufacturing and marketing with the assurance of the reliability of data from non-clinical and clinical studies in R&D stage and of the quality of investigational drugs. Upon the obtainment of manufacturing and marketing approval, those in the three responsible posts (general marketing supervisor, quality assurance manager, and safety manager) work closely together to constantly ensure compliance with all related laws and regulations and the fulfillment of requirements under which approval has been granted, product quality assurance, and safety assurance.

Quality Policy for Pharmaceuticals

To help people lead healthier, happier lives, Nippon Shinyaku strives to ensure a stable supply of high-quality, innovative products that meets and exceeds our customers’ expectations while complying with all local and regional governmental laws and health authority regulations.

Nippon Shinyaku Quality Policy for Pharmaceuticals(April 1, 2022)

Quality System for Pharmaceuticals

To deliver high-quality products to patients in Japan and around the world, we have established a quality system that meets global standards to ensure product quality. We conduct a periodic management review to continuously improve the quality system, product quality, and resource distribution based on risk assessment. We also have a recall system in place in anticipation of eventualities.

Safety Assurance

We have adopted a risk management plan for pharmaceutical drugs, according to which risk and benefit are studied throughout all processes, from product development to marketing, and necessary safety measures are implemented. We collect, examine, and evaluate safety reports (on adverse effects and so forth) from within and outside Japan, promptly providing information necessary to ensure product safety to healthcare providers.