With the health and wellbeing of patients at stake, any organization that is certified as a marketing authorization holder for pharmaceuticals must commit to product quality assurance and safety management. In Japan, as in many countries around the globe, management of the quality and safety of pharmaceutical products must be carried out in accordance with the law* and regulations enforced by the Ministry of Health, Labour and Welfare. It is essential for pharmaceutical companies who are marketing authorization holders to have a system in place that ensures total compliance.

The regulations stipulate the following: Under a general supervisor, the pharmaceutical company must have a quality assurance department and prepare a quality standard code which contains up to date information on each of their products, including drug composition and manufacturing methods. A quality assurance duty procedure document containing details on procedures such as manufacturing control, quality assurance, market release, storage and training must be prepared. Vigilance practices must be in place to continuously manage feedback. A safety control management department is necessary, also under the purview of the general supervisor, where safety control information is gathered from medical institutions and partner companies. All feedback, including things such as adverse reactions or ineffectiveness, must be evaluated.

*The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

Under the regulations set by the Ministry of Health, Labour and Welfare, it is necessary for anyone working in a post-sale products safety management role to participate in ongoing education and training, as well as self-auditing. At Teijin Pharma, our Compliance Division handles this too. The Medical & Pharmaceutical Information Department provide relevant educational opportunities for all medical representatives (MRs), providing online questionnaires that act as both educational materials and self-auditing tools. Both quality assurance departments, one focused on pharmaceuticals/drugs, the other on medical devices, provide educational lectures on regulatory compliance relevant to their respective fields.

On top of these ongoing educational programs, we also hold annual lectures for all Teijin Pharma members, covering topics that are relevant to all. In 2018, the topic was drug-induced suffering. Introducing historic cases in Japan, such as the mishandling of blood products leading to patients contracting hepatitis C, the lecture highlighted preventable cases of drug mishandling. In the hepatitis C outbreak case, many patients were affected and the resulting lawsuit led to much stricter laws and regulations. Through studying these historic cases, members can better understand the importance of compiling data from around the world to strengthen our safety measures. In 2019, the topic was counterfeit medicinal products, discussing the rising volumes of drugs that are imported to Japan through unregulated channels. Customers are sometimes duped into buying counterfeit products slipped in with officially certified products, underlining the importance of managing raw materials, packaging materials and controlling where our products go.