Society > Together with Patients and Healthcare Professionals Drug Safety / Quality Assurance

Quality Assurance System of Drugs

In April 2020, we established the Quality & Vigilance (QV) Division to function as the global head of quality and safety management for products. The QV Division has the following functions.

Primary Functions of the QV Division
  • Creation of a mechanism and system for the stable supply of high-quality products
  • Audits to ensure the reliability of each operation from research and development to post-marketing
  • Collection and analysis of safety information of products and products under development, and the reporting and dissemination of that information
  • Formulation and promotion of safety information surveillance policies for post-market products

To ensure that our pharmaceuticals can be used by healthcare professionals and patients with peace of mind, the Quality Assurance Department strives to maintain and improve our system of reliability assurance by complying not only with “The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices,” but various laws and regulations including GMP, GQP, GDP, and GVP.

In May 2017, we obtained approval for Radicava as a treatment agent for amyotrophic lateral sclerosis (ALS) in the U.S. Subsequently, we also obtained approval in Switzerland, Canada, and other countries, and have accelerated product rollout in regions where we have not established our own sales system*. More than ever, we are providing products that comply with the regulations of each country while collaborating with the quality and safety departments in each country. Always mindful of differences in medical environments, we provide patients around the world with products that they can use with peace of mind.

The Group will continue to ensure the quality, effectiveness, and safety of pharmaceutical products by complying with laws and regulations and maintaining and improving its quality assurance system.

*A system of direct sales as well as sales by licensed overseas companies. The establishment of a direct-sales system enables independent operation as a pharmaceutical company.

System to Assure the Reliability of Drugs
  • *GLP (Good Laboratory Practice)
    Standards for conducting preclinical trials on pharmaceutical safety
  • *GCP (Good Clinical Practice)
    Standards for conducting clinical trials of pharmaceuticals
  • *GMP (Good Manufacturing Practice)
    Standards for manufacturing and quality control of pharmaceutical and quasi-pharmaceuticals
  • *GQP (Good Quality Practice)
    Standards for quality control of pharmaceuticals, quasi-pharmaceuticals, cosmetics, and medical devices
  • *GVP (Good Vigilance Practice)
    Standards for pharmaceutical post-manufacturing and marketing safety management

New Drug Safety Management

After the launch of a new drug, adverse drug reactions that were not discovered in clinical trials are sometimes reported. We quickly collect that information, analyze it, and provide feedback to the medical front lines. We are moving forward with proactive safety management activities that incorporate new safety measures. We believe that these activities help prevent the expansion of adverse drug reactions from new drugs and promote appropriate usage on the medical front lines.

Radicut (Japan product name), which was discovered by the Company, was approved in Japan in 2001 as treatment agent for the acute stage of cerebral infarction and has been in use for more than 15 years. Subsequently, it acquired an additional indication in Japan for Amyotrophic Lateral Sclerosis (ALS) in 2015, and it was approved as an ALS treatment agent in South Korea in December 2015 and in the U.S. in May 2017 (U.S. product name: Radicava). After U.S. approval, we will continue to advance global initiatives with a view to other countries and regions. When Radicava is used overseas, it is used in a medical environment that is different from that in Japan, and accordingly it will be necessary to exercise caution in safety management. Based on the abundant safety information that we have accumulated in regard to Radicut and Radicava, we have valuable experience in promoting proper use. Making full use of that experience, and giving consideration to the overseas regulatory and medical environments, we will work to collect and provide safety information to foster the proper use of Radicut/Radicava and to contribute to improvement in the quality of life of ALS patients.

Post-Marketing Surveillance in Japan

After the regulatory authority approves the manufacturing and marketing of a drug based on the results of nonclinical and clinical studies, we begin selling the drug. Clinical studies are conducted with the number of subjects that are required to scientifically verify the efficacy and safety of the new drugs. However, the conditions for participation in clinical studies (age, medical history, concomitant medications, etc.) are not necessarily the same as the post-marketing conditions of use.

Therefore, the Company starts to collect safety information under actual conditions of use at medical sites as soon as drugs are launched, and we also conduct various post-marketing surveillance. Through the surveillance, we aggregate safety information regarding the drugs that have been actually prescribed to patients, we monitor the safety and efficacy of drugs, and the information that is obtained in the surveillance is quickly and accurately provided to the regulatory authorities and healthcare professionals. In this way, we are working to support the proper use of drugs.

Post-Marketing Safety Management and Surveillance of Safety in Japan

Quality of Products

Our policy is to contribute to the health and well-being of people around the world through the stable supply of high quality, reliable products which are manufactured under a world-class quality system. On that basis, we are strictly observing the ministerial ordinance on GMP (regulations regarding pharmaceutical manufacturing control and quality control) and on GQP (regulations regarding pharmaceutical quality control). Patient safety is the first priority of every employee, and we are implementing initiatives targeting quality assurance with a focus not only on results but also on processes. Through management, supervision, and guidance of manufacturing sites in Japan and overseas, we are working to improve the quality of the products that we provide to the market.

Furthermore, we are working to ensure the quality of pharmaceuticals in accordance with a division notification from the Ministry of Health, Labour and Welfare dated June 1, 2016, regarding the carrying out of production based on the certificate of approval for manufacture and sales.

Quality Assurance Initiatives
  • Strengthen collaboration with manufacturing plants and reinforce checking systems, and regularly confirm actual manufacturing practice and the certificate of approval
  • Enforce measures to prevent recurrence by rectifying and improving any defects based on our own checks and investigations at manufacturing plants

Pharmaceutical Safety Training

Every year since fiscal 2008, the Company has systematically and continuously implemented Group-wide pharmaceutical safety training. These training initiatives are for directors, executive officers, presidents and other executives of Group companies, and all employees, including those of Group companies. The objective of this training is to accumulate and pass on knowledge, and raise awareness related to pharmaceutical safety.

In fiscal 2019 training, we learned from past drug induced suffering that “one of the causes of the spread of health hazards is the delay from the time that the risk is predicted and warned of until corrective action is taken,” and we reaffirmed the importance of sharing drug safety information among pharmaceutical companies, healthcare professionals, countries and citizens. We also learned the importance of predictive and preventive safety management by promoting the proper use of drugs by taking real-life examples of product literature for patients on Radicut/Radicava, which has been approved in six countries (as of July 2020). This training was an opportunity to reaffirm, as workers in the pharmaceutical industry, the importance of having each worker improve their risk sensitivity and always act with the patient's health and safety as their highest priority.