Consumer Issues Drug Safety / Quality Assurance

Quality Assurance System of Drugs

To ensure that our pharmaceuticals can be used by healthcare professionals and patients with peace of mind, reliability in terms of quality, efficacy, and safety is important.
We are working to secure efficacy, quality, and safety by strictly observing the appropriate standards for ensuring reliability, as stipulated by "The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices." In addition, we acquired NDA approval for our product in the U.S. in May 2017, and accordingly we are providing products with assured reliability in the U.S as well. In this way, while complying with the regulations of each country, we will provide products that can be used with peace of mind to people all over the world, with the difference in medical circumstance always in mind.
To strictly observe laws and regulations and to meet the requests of society, the Group will continue working to maintain and enhance its quality assurance system.

System to Assure the Reliability of Drugs
  • *GLP (Good Laboratory Practice)
    Standards for conducting pre-clinical trials on pharmaceutical safety
  • *GCP (Good Clinical Practice)
    Stands for conducting clinical trials of pharmaceuticals
  • *GMP (Good Manufacturing Practice)
    Standards for manufacturing and quality control of pharmaceuticals and quasi-pharmaceuticals
  • *GQP (Good Quality Practice)
    Standards for quality control of pharmaceuticals, quasi-pharmaceuticals, cosmetics, and medical devices
  • *GVP (Good Vigilance Practice)
    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 further 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, 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, we are continuing to strengthen collaboration with manufacturing plants and reinforce checking systems, and regularly confirm the actual manufacturing practice and the description in the certificate of approval for manufacture and sales. In addition, through collaboration with related in-house units, we will ensure that we have an appropriate system for change management implementation. Furthermore, in accordance with self-checks conducted by manufacturing plants and surveys conducted by Mitsubishi Tanabe Pharma, we will work to rectify and improve the situation if there are any deficiencies, implement thoroughgoing measures to prevent a recurrence, and secure pharmaceutical quality.

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 related to pharmaceutical safety.
In fiscal 2018, we conducted training on variety of themes, such as pharmaceutical safety using lessons learned from incidents of health problems caused by pharmaceuticals, and pharmaceutical company activities implemented to appropriately manage pharmaceutical risk. We discussed what could be done at each workplace by people who work at pharmaceutical companies. By learning from past drug induced suffering, we renewed our pledge to prevent the recurrence of drug induced suffering, and reaffirmed the need for risk sensitivity and an ethical viewpoint in daily activities. In addition, we reaffirmed the importance of always acting with the highest priority on the safety of patients in all our business activity processes, including being aware that pharmaceutical safety management is a social duty of pharmaceutical companies and doing our utmost to advance appropriate usage.