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Pharmacovigilance and Quality Assurance

Pursuant to its Quality Assurance Policy, the Kyowa Hakko Kirin Group is committed to providing products and services that earn the satisfaction and trust of its customers.

Kyowa Hakko Kirin Group Quality Assurance Policy

  • We strive to maintain a high level of quality and provide products and services that achieve customer satisfaction.
  • We comply with relevant laws and regulations, place top priority on safety, and sincerely engage in quality assurance activities to provide products and services trusted by customers.

Quality Assurance System

The Kyowa Hakko Kirin Group has in place a three-tier monitoring system to ensure that its quality assurance system is functioning properly. Under the system, quality assurance organizations are established at each plant, as well as for each business field, and the Corporate Quality Management Department oversees the quality assurance activities of the entire Group. Our quality assurance activities are performed in compliance with relevant laws and regulations, with top priority on customer safety, and in step with the changing business environment.

Quality Assurance of Pharmaceutical Products

Under the Policy for Safety, Quality and Regulatory Affairs in Pharmaceutical Business, Kyowa Hakko Kirin strives to supply pharmaceutical products of excellent quality, along with high-value-added information, to customers with the aim of contributing to their health and well-being.

Policy for Safety, Quality and Regulatory Affairs in Pharmaceutical Business

We will supply products of excellent quality along with reliable information to customers.

In keeping with our Policy, we adhere to the following four principles (4Cs)

Sincere response (Cordiality)
Activity with all members participating (Cooperation)
Consistent reliability assurance system (Consistency)
Compliance with laws and regulations and responding to social demands (Compliance)

To provide customers with a stable supply of high-quality pharmaceutical products offering guaranteed safety and efficacies, we assure reliability in all phases of our activities from research and development to post-marketing by complying with the Pharmaceutical and Medical Device Act (former Pharmaceutical Affairs Act), and related laws and regulations including the Good Manufacturing Practice (GMP), Good Quality Practice (GQP), and Good Vigilance Practice (GVP) guidelines. In our efforts to make progress toward becoming a Global Specialty Pharmaceutical Company (GSP), we are focusing on establishing a quality assurance and safety management system fulfilling global standards in preparation for launching pharmaceutical products in Europe and the United States.

Ensuring Global Standard Quality of Pharmaceutical Products

In 2010, we formulated our own guidelines in line with the ICH Q10 pharmaceutical quality system guidelines (hereafter, “ICH Q10”)*1, taking rigorous steps to build a global quality assurance system. The Plan-Do-Check-Act (PDCA) cycle for manufacturing management and quality control incorporates reviews performed by the top management team including the president and CEO, and the top management team assumes clearly defined roles and responsibilities in ensuring the effective implementation of the ICH Q10. Furthermore, we undertake knowledge management and product lifecycle management, which are also elements covered in the ICH Q10.

In 2014, Japan was approved to join the Pharmaceutical Inspection Co-operation Scheme (PIC/S; joint name for the Pharmaceutical Inspection Convention [PIC] and the Pharmaceutical Inspection Cooperation Scheme [PIC Scheme]), which is an international standard required to be met in GMP inspection. In response, Kyowa Hakko Kirin is strengthening its global manufacturing/quality control system with an emphasis on fulfilling PIC/S requirements. In addition, given the advancement of our products into the global market, we have set our own guidelines in line with the internationally recognized EU/WHO Good Distribution Practice (GDP) guidelines and are working to reinforce our system in order to ensure proper management of pharmaceutical products in the distribution process.

ICH stands for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The Q10, one of the guidelines developed by the ICH, concerns the quality of pharmaceutical products, and presents a pharmaceutical quality system model that also meets the GMP guidelines.

Rigorous Pursuit of Pharmacovigilance Activities

All pharmaceutical products carry both benefits for patient treatment and risks in the form of adverse side effects. The balance of benefits and risks of a drug changes throughout the entire process from the development phase through regulatory check and approval to post-marketing. To afford greater safety and peace of mind to patients using our pharmaceutical products, we implement appropriate assessments and reviews of drug benefits and risks and work thoroughly on our pharmacovigilance activities including providing appropriate information to those at the front lines of healthcare.

Furthermore, Kyowa Hakko Kirin has been working to centralize management of all pharmaceutical safety information obtained in Japan, the United States and Europe, and create a system where information can be seamlessly collected, assessed and communicated across the three markets. In 2016, we began full operation of the Global Safety Database based on collaboration among the three regions.

In our belief that the continued execution of our Risk Management Plan (RMP)*2 forms the basis of our pharmacovigilance activities, we intend to continue making full use of the scheme.

Under the RMP, the benefits (effects) and the risks (side effects) of a drug are assessed and reviewed throughout the entire process from the development stage to the post-marketing stage. Necessary safety measures are taken based on the assessment results with the aim of ensuring post-marketing safety and proper use of the drug.

Measures against Risks and Disasters

We have been providing all employees engaged in pharmaceutical business with education on the risks of drugs, including the history of health hazards caused by drugs, and on the GVP guidelines in our belief that it is our responsibility as a pharmaceutical company to do so.
To enable us to respond promptly and appropriately should a risk concerning one of our products materialize, we perform joint training with external manufacturing contractors and conduct global recall drills involving all sales sites including those outside Japan.
Moreover, we have in place our Business Continuity Plan (BCP) for our reliability assurance activities to sustain our important responsibilities of supplying pharmaceutical products and providing information in the event of a large-scale earthquake or other disasters. Notably, we have formulated concrete BCP action manuals for our pharmacovigilance activities and product shipment validation procedure, which must be continued without interruption. This is because these activities include collection and provision of safety information, and assessment, reporting and provision of findings, which are critically important operations required of a pharmaceutical company.

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