The Kyorin Group is committed to proactively addressing sustainability issues through its pharmaceutical business of developing and providing useful and safe products and services to society. Throughout this process (from research and development through the disclosure of product information and the appropriate use of drugs), Kyorin Pharmaceutical Co., Ltd., is committed to respecting the human rights of all people and abiding by all relevant laws and regulations including the Act on Pharmaceuticals and Medical Devices.
Main initiatives
Research (Drug discovery)
Ethical considerations for human drug research
The company conducts research on humans, obtains human derived test materials and information, and carries out research using those materials with the consent of participants through appropriate responses in accordance with the Declaration of Helsinki* and the relevant laws, regulations, and guidelines of each country.
Researchers also undergo ethical education and training related to bioethics, genome research, and clinical research, and the Company strives to respect the human rights and protect the personal information of the people who cooperate in this research.
Also, in line with the Ethical Guidelines for Medical and Biological Research Involving Human Subjects, the Company has created a Research Ethics Investigation Committee, which includes outside experts, to impartially and fairly inspect the ethicality and scientific validity of research plans.
* The Declaration of Helsinki is a set of ethical principles regarding human experimentation that governs doctors and other professionals involved in medical research
Ethical considerations for the use of animals in experiments
Animal experiments are essential in the research and development of drug to promote human health. The Company has an internal committee that inspects all experiments from the perspective of the 3R principals-refinement (reduction of animal distress), replacement (substitution of animal experiments with alternatives), and reduction (decrease in the number of laboratory animals used)- based on the Act on Welfare and Management of Animals (animal welfare legislation) and the “Basic Policies for the Conduct of Animal Experimentation in the Institutions under the Ministry of Health, Labor and Welfare” to ensure that animal experiments are carried out appropriately from a scientific perspective that considers the animals’ welfare. Regular independent inspections are also done to confirm that the conditions related to the raising of laboratory animals and animal experiments are in regulatory compliance. Surveys are conducted and certification is obtained from the Japan Pharmaceutical information Center’s Center for Accreditation of Animal Experimentation Institutions, a third-party organization based on guidance from the Ministry of Health, Labor and Welfare.
Biotechnology and countermeasures against biohazards
KYORIN Pharmaceutical Co., Ltd. has established rules based on the "Cartagena Law" in order to properly carry out genetic recombination experiments, and an in-house committee reviews the contents of each experiment.
In addition, in order to properly handle pathogens, we have established rules that comply with the "National Institute of Infectious Diseases Pathogen Safety Management Regulations", and an internal committee examines the handling of each pathogen. The committee regularly educates workers involved in these studies in an effort to prevent experimental accidents and legal violations.
Use of genetic resources
KYORIN Pharmaceutical Co., Ltd. complies with the purpose of the Convention on Biological Diversity, the opportunity to acquire genetic resources under the Nagoya Protocol, and the rules for fair and equitable distribution of benefits arising from its use.
Since the environmental, biodiversity, and human impacts of the use of new recombinant organisms have not been clarified, we comply with the Cartagena Protocol and regulations to conserve biodiversity, give consideration to ethics and handle it carefully.
Handling of intellectual property
The protection of intellectual property is important for maintain competitiveness while meeting unmet medical needs, and the Company has formulated internal guidelines for handling intellectual property.
In our core areas for research and development, we are working proactively to protect intellectual property and concentrating our investment in acquisition of intellectual property rights to create an intellectual property portfolio that contributes to business continuity. The Company is also putting effort into intellectual property landscape activities based on an analysis of patent information, to share intellectual property information with research divisions and contribute to building a future research and development pipeline.
Clinical development
Respect for subjects’ human rights, security of personal information,
and maintenance of trust during clinical trials
The Company carries out clinical trials in line with the Declaration of Helsinki and relevant laws and regulations governing clinical trials of pharmaceuticals, including good clinical practice (GCP), with full consideration given to protecting the human rights and personal information of trial subjects, to confirm that candidate substances for new drugs are effective and safe. Clinical trial plans are approved after inspection for ethicality and scientific validity by internal and external committees. Moreover, clinical trials are carried out after the subjects are fully informed about items including the objectives of clinical trials and their methods, anticipated merits and demerits, and compensation in the event of damage to their health.
Confirmation that subjects understand the details and have given their consent to participate is required. In addition, employees involved in clinical trials receive education and training, and clinical trial institutions are monitored to ensure that the clinical trials are appropriately carried out in compliance with GCP. The Company also strives to manage clinical trial data properly to ensure that the subjects’ privacy is protected. In addition, it regularly confirms that clinical trials done externally are carried out in conformity with the same standards.
Disclosure of information related to clinical trials and trial results
The Company is working to improve transparency by disclosing clinical trial plans and results. Plans for clinical trials led by the Company are posted on a clinical trial database available to the general public. Going forward, the Company will promote the creation of an environment for appropriate access to clinical trial data by researchers and others who might use that data, disclosing information to maximize the value of clinical trial data and playing a role in the advancement of science and promotion of innovation. Information disclosure methods are currently being reviewed, and the policy for the disclosure of clinical trial data will be released when it is finalized.
Increased access to investigational new drugs
The company stipulates "The rule on request for an extended clinical trial ", and from a humanitarian point of view, we summarize the measures to be taken in case when we receive a request for investigational drugs from a medical institution for the reasons other than clinical trials, or when we receive a request from a regulatory authority.
Some patients with serious or life-threatening illnesses are unable to receive the investigational drug because all existing treatments have been ineffective and do not meet the criteria for participation in clinical trials.
This rule is intended to give consideration to those who wish to receive the investigational drug but cannot receive it due to various reasons.
Technological development and manufacturing
Quality assurance
The Company believes that it must continuously provide products and information widely trusted by society. That is its highest priority. The company is focused on centrally monitoring all operations related to reliability assurance, from development to sales, complying with relevant laws and regulations, and maximizing the continuation of trust. The Quality Assurance & Reliability HQs, which plays a central role in this effort, is independent from research and development, manufacturing, and sales divisions, and works to provide products and information that can be used by patients and medical professionals with peace of mind.
At the development stage, the quality of investigational new drugs is assured based on standards related to their manufacturing management and quality control (investigational new drug GMPs)
After sales (after manufacture and sales), we strive to maintain the quality of products by guaranteeing quality in accordance with good quality practices (GQPs) for pharmaceuticals and other products including confirmation that each product is made with appropriate equipment according to a designated procedure manual. Quality inquiries from patients and medical professionals after sales are acknowledged and answered sincerely and swiftly.
Stable supply
With the increase in global products and the diversification of modality, supply chains are becoming increasingly complex. Given these changes, the Company has built a structure for stable supplies that makes it possible to visualize and centrally manage demand forecasts, inventory information, and supply plans for all regions around the world. This structure enables global management from the manufacture of pharmaceutical ingredients to the supplying of products. We are also aiming to build an even more resilient supply chain to respond flexibly to recent changes in business conditions.
The pharmaceutical supply chain, which encompasses a wide variety of items including raw materials, intermediates, and pharmaceutical ingredients, is supported by numerous suppliers in Japan and overseas. To continue to provide stable supplies without interruption in the procurement chain, the Company considers it imperative to strengthen relationships with individual suppliers by working closely together and sharing information. As another risk hedge, it is striving to secure multiple alternative suppliers in addition to existing suppliers and various types of alternative transport routes. Stable supplies are also being strengthened with the promotion of compliance in logistics, including imports and exports.
To achieve even more stable supplies, appropriate warehousing standards and procurement plans are formulated for individual products. For products that fluctuate because of seasonal factors or sudden popularity, the Company strives to carry out flexible procurement while monitoring changes daily in close cooperation with internal marketing divisions.
With the appearance in recent years of geopolitical risk, exchange rate fluctuations, high costs for raw materials for reasons including higher energy prices and shortages of semiconductors, and the “2024 problem” in logistics (a projected shortage of drivers in Japan as a result of new overtime regulations taking effect), the Kyorin Group is working continuously to mitigate these various risks and maintain stable supplies through initiatives including coordinating production plans and inventories with internal and external subcontractors, diversifying and cultivating alternative suppliers, and making logistics more efficient.
Prevention of medical malpractice and improvement of drug discrimination
The Comaany always strives to provide products from the user's point of view in order to prevent accidents in which patients and medical personnel mistake drugs. In addition to printing the product name directly on capsules and tablets, we are working to prevent medical malpractice by making it possible to identify the drug name and content even if the packaging sheet (PTP sheet) is divided.
In some products, in order to prevent mistakes in the display of the PTP sheet, we have adopted easy-to-read colors and typefaces for the PTP sheet to improve visibility. In addition, the product name is printed on the tablets to prevent them from being mistaken for other drugs when wrapped in a package.
Relations with local communities
The Company actively strives for environmental conservation and pollution prevention with the priority themes of "preventing global warming," "resource protection," and "harmony with the natural environment," and collaborate with the local community for sustainable pharmaceutical production. We promote social contribution activities in cooperation with each other and realize coexistence with society.
Details of specific community contribution activities:
- Active and continuous participation in local cleanup activities
- Invite local people to a summer festival as an opportunity for dialogue
- Participate in blood donation activities
Provision of product information
Promotion of the appropriate use of drugs
Mistakes in the use of drugs can damage a patient’s health, while side effects can also occur even when drugs are used correctly. In those cases, the Company’s medical representatives (MRs) work to accurately and swiftly provide information for appropriate product usage to allow medical professionals to use drugs more effectively and safely.
We also collect information from medical facilities that use our proprietary products about the products about the products’ effectiveness and safety, and pass on the results of the analysis and evaluation of that information to medical professionals. Given the Company’s MRs’ mission of contributing to better health, MRs act with a strong sense of ethics and work in strict compliance with relevant laws and regulations, guidelines, industry rules, and internal guidelines, including our Corporate Charter.
Response to drug inquiries
The Company feels a responsibility to provide highly reliable drug information that is both fair and impartial in response to inquiries from patients and medical professionals. By fulfilling this responsibility, the Company promotes the appropriate use of products that are safe and effective. With this understanding, it established the Drug Information Center to answer various inquiries.
We are continuously working to improve our response to pharmaceutical product-related inquiries by using objective, accurate, and the most up-to-date data to provide consistent, appropriate, and correct information. These efforts allow the Company to answer inquiries concisely, swiftly, and accurately, and are also useful for analyzing the needs of patients and medical professionals and managing product life cycles. The Company uses a global medical information system to provide high-quality responses to inquiries from patients and medical professionals.
Number of inquiries: Approximately 23,500 (fiscal 2022)
Procurement（SCM）
Initiatives to ensure sustainable procurement
The Company considers it important to fulfill its social responsibility by striving to provide stable supplies of products through optimal supply chain management and asks suppliers for cooperation based on their own social responsibility.
The Company carries out sustainable procurement with s strong sense of ethics, in compliance with both the letter and the spirit of laws, regulations, and international rules in Japan and overseas, while promoting environmental awareness including reducing the use of chemical substances and waste.
On-site supplier investigations
When selecting a new supplier, we begin transactions only after confirming through an on-site investigation that the supplier has measures in place for legal and regulatory compliance, labor safety, and environmental protection.
We regulatory visit suppliers with whom we have business relationships to continuously maintain and enhance product quality and stable supplies. We also carry out risk evaluations in areas like work environments (including measures to prevent employee from being exposed to chemical substances), measures to reduce waste, and measures to lessen the environmental impact of wastewater and exhaust emissions from manufacturing activities.
When on-site investigations identify items needing correction, we propose improvement status.
Activities with patients and medical professionals
Providing information via “Doctor Salon”
We sponsor “Doctor Salon,” a radio program for physicians on Radio NIKKEI DAIICH that answers questions related to day-to-day clinical practice from general practitioners across Japan. In addition, the program’s content is distributed as a brochure, with back issues available via a website, and the audio of “Doctor Salon” is distributed as a podcast.
“Doctor Salon” is extremely popular with physicians, especially primary-care doctors.
Public websites for medical professionals and patients
We strive to meet the information need of medical professionals by posting product-related information, and other information useful in daily medical care on Kyorin Medical Bridge and other websites for medical professionals.
We also strive to increase patient adherence to guidelines by providing information on how to take medicine properly, information about disease, and other information on websites for patients.
Providing information about disease
We assist medical professionals in creating disease information tools for informed consent from patients, with the aim of helping patients correctly understand disease and improving their quality of life (QOL).
Support the Department of Drug Discovery Medicine
We helped establish and support the Department of Drug Discovery Medicine at Kyoto University Graduate School of Medicine to cultivate innovative human resources for Japan’s drug discovery in the post-genome era through cooperation with industry and academia.
Support for Medical Education Project
We contribute to the improvement of quality in medical educational opportunities for medical professionals and improving their knowledge and skills though support for the Medical Education Project, planned and managed by Japanese Society of Otorhinolaryngology Head and Neck Surgery, Inc.
Reliability Assurance
We have established a detailed reliability assurance system for the products we handle and aim to gain the trust of wide segments of society by ensuring compliance with relevant laws and regulations, assuring reliability, guaranteeing quality, and pursuing safety management.
Reliability assurance system
Group complies with the Good Quality Practice (GQP) and Good Vigilance Practice (GVP) standards for pharmaceuticals.
In the diagnostics business, we have established a system that conforms to the Quality Management System (QMS) standard for manufacturing and managing medical devices and in vitro diagnostics and quality control.
Our Quality Assurance & Reliability Division, which plays a central role in this process, is independent of the R&D, manufacturing, and sales divisions. It engages in unifi ed product reliability assurance initiatives to provide products and information that patients and medical practitioners can use with confidence.
In addition, we promote proper use of our products and assure their reliability by faithfully and promptly responding to aftersales inquiries from patients and medical practitioners about products’ efficacy, safety, and quality.
Quality assurance
The Kyorin Group has a quality policy for both ensuring product quality and providing stable supplies. We are strengthening operation of our manufacturing centers through management of quality risk based on scientific evidence.
For pharmaceuticals, we are building a structure to supply high-quality products based on GMP standards in cooperation with Group plants and other facilities from the development stage. We have also set up a distribution system that conforms to Good Distribution Practice (GDP) standards for pharmaceutical products.
After launches, we conduct quality assurance in compliance with GQP standards to ensure the quality and stable supply of products, from development and manufacture to distribution. For in vitro diagnostics and medical devices (diagnostics business), we are committed to providing high-quality products by practicing quality assurance in compliance with QMS standards across all stages, from design and development to sales. To maintain product quality and ensure integrity during the distribution process, we have established a GDP-compliant distribution system.
Under this system, which includes on-site inspections, we confirm that quality control is performed properly at storage and distribution companies.
Safety management
Drugs can be effective for treating patients (benefits) but can also have adverse side effects (risks).
Therefore, during the developments phase, we collect and manage safety information on investigational new drug and appropriately monitor and evaluate changes in the safety profile of those drugs. After a product is launched, moreover, side effects unforeseen during the development phase may become apparent.
For this reason, it is important to collect and analyze a wide range of information about benefits and risks after a product is launched and to quickly provide appropriate information to the medical community, with the balance taken into account.
The Kyorin Group formulates risk management plans and collects and manages safety information by individual product. We also conduct drug monitoring activities for pharmaceuticals and medical devices in compliance with GVP standards to ensure their safety and proper use. In addition, we conduct postlaunch investigations to collect and evaluate information on the safety and efficacy of pharmaceuticals in compliance with Good Post-marketing Study Practice (GPSP) standards.