GLP: Good Laboratory Practice, pharmaceutical safety-related standards for non-clinical trials; GCP: Good Clinical Practice, standards for pharmaceutical clinical trials; GMP: Good Manufacturing Practice, standards for production management and product quality management of pharmaceuticals and other items; GQP: Good Quality Practice, standards for product quality management of pharmaceuticals and other items; GDP: Good Distribution Practice, standards for proper distribution of pharmaceuticals; GVP: Good Vigilance Practice, standards for post-production marketing safety management of pharmaceuticals and other items; GPSP: Good Post-Marketing Study Practice, standards for post-production marketing survey and study practices of pharmaceuticals

Main initiatives (Kyorin Pharmaceutical Co., Ltd.)

Research

Ethical considerations for human drug research

Kyorin Pharmaceutical conducts research on humans and research on samples derived from humans with their full consent in an appropriate manner and in line with　the Declaration of Helsinki,* and the relevant laws, regulations, and guidelines of each country. It also conducts ethical education and training for　researchers in bioethics and genome research and clinical research, and endeavors to respect the human rights and protect the personal information　of research participants. We have established a human tissue research ethics investigation committee, which includes outside experts, to inspect the ethicality and scientific validity of research plans in a neutral and fair manner.

* 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 trials

Animal experiments are indispensable for the research and development of medicines that maintain and improve human health. To conduct appropriate animal trials from a scientific perspective while taking into consideration of the protection and welfare of animals, Kyorin Pharmaceutical has established rules based on “Act on Welfare and Management of Animals” and ”Guidelines for conducting animal experiments at the executing agency under the jurisdiction of the Ministry of Health, Labor and Welfare” etc. Also the company has reviewed the content of each experiment to promote strict adherence to the 3R principles -refinement (reduction of animal distress), replacement (substitution of animal experiments with alternatives), and reduction (decrease in the number of laboratory animals use)- and various policies to protect animals. In addition, we carry out regular self-inspections to confirm compliance with the regulations regarding the breeding of laboratory animals and the implementation status of animal experiments. In addition, based on the guidelines of the Ministry of Health, Labor and Welfare, as a third-party verification organization, we have obtained certificate after investigated by Center of Accreditation of Laboratory Animal Care and Use, Japan Health Sciences Foundation.

Biotechnology and countermeasures against biohazards

Kyorin Pharmaceutical 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 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

Appropriate protection of intellectual property is important for responding to unmet medical needs while maintaining competitiveness, and Kyorin Pharmaceutical has established an "intellectual property concept".

Clinical development

Respect for subjects’ human rights, security of personal information, and maintenance of trust during clinical trials

Kyorin Pharmaceutical conducts clinical trials to confirm the efficacy and safety of new drug candidate substances in line with the Declaration of Helsinki* and relevant laws and regulations governing clinical trials of pharmaceuticals, including Good Clinical Practice (GCP), while fully considering the human rights and personal information of trial subjects.
Its clinical trial plans are approved after inspection for ethicality and scientific validity by internal and external committees. Moreover, it must give subjects sufficient explanation of items such as the objectives of trials and the methods used, the expected merits and demerits, and compensation in case of damage to the health of subjects, and confirmation is needed that subjects understand the details and have given their consent to participate. In addition, checks are made to ensure that employees involved in trials have been properly educated and trained, and monitored that trial institutions respect GCP, and trials are conducted appropriately.

Disclosure of information related to clinical trials and trial results

Kyorin Pharmaceutical strives to disclose clinical trial plan and its results and improve its transparency. Regarding clinical trial plan that we lead, we publicly disclose them at the clinical trial databases. From now on, we will disclose information to promote the creation of appropriate clinical data access environments for those possibly involved in utilizing clinical trial data, including researchers, and maximize its value and promote the disclosure of information that is useful in scientific progress and innovation. We are currently considering information disclosure methods, and will present them as a policy on disclosure of clinical trial data as soon as they are ready.

Increased access to investigational new drugs

Kyorin Pharmaceutical 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 production

Stable supply and quality management

Kyorin Pharmaceutical contributes to medical care by observing laws, regulatory requirements and internal standards, and stabl supply of high-quality products to customers. In particular, we practice faithfully under the Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) of pharmaceutical products, which are important to deliver high-quality pharmaceutical products. All employees through continuous improvement are working hard to make better products.

Quality assurance

Kyorin Pharmaceutical believes that it is necessary to continuously provide products and information that are widely trusted by society, and that this is an initiative that must be implemented with the highest priority. We centrally manage all operations related to reliability assurance from R&D to sales, comply with relevant laws and regulations, and focus on ensuring reliability as much as possible. The Reliability Assurance Headquarters, which plays a central role in this, is independent of the R&D, production, and sales departments, and aims to provide products and information that patients and medical personnel can use with confidence. At the development stage, quality assurance of the investigational drug based on GMP, and after marketing (after manufacturing and sales), quality assurance in compliance with GMP and GQP, we confirm that the product is manufactured according to the procedure manual specified by appropriate equipment. We are conscious of responding sincerely and promptly to quality inquiries from patients and medical personnel after marketing.

Stable supply

The supply chain is becoming more complex due to the increase in global products and the diversification of modality. The company has created a stable supply structure based on demand forecasts for each region of the world and the unified management of inventory information and supply plans, making it possible to globally manage every stage of the process from ingredients manufacturing to supply of finished products.
The pharmaceutical supply chain includes a wide variety of diverse items, including raw materials, intermediates, and pharmaceutical ingredients and is supported by a large number of suppliers in Japan and overseas. To maintain a stable supply, it is essential to strengthen ties with individual suppliers and ensure close alliances and information sharing. Moreover, as one of its risk-hedging policies, we strive to identify multiple alternative suppliers to supplement existing suppliers and different types of transportation routes. We are also promoting logistics compliance, including imports and exports, to strengthen stable supply.
In addition, in order to realize a more stable supply, we have set appropriate inventory standards for each product and are proceeding with procurement plans, but for products with variable factors such as seasonality and epidemic season, we cooperate with the in-house sales department every day. We strive for flexible procurement while grasping the changing situation.

Prevention of medical malpractice and improvement of drug discrimination

Kyorin Pharmaceutical 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

Kyorin Pharmaceutical 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. The company’s medical representatives (MR) work to accurately and swiftly provide information for appropriate product usage to allow medical professionals to use drugs more effectively and safely. In addition, we collect, analyze, and review information on efficacy and safety gleaned from the use of our drugs, and transmit the results to medical professionals. Kyorin Pharmaceutical's MRs act based on high ethical standards with a sense of mission to contribute to people's health, and strictly comply with internal rules including related laws and guidelines, industry rules, and Kyorin Pharmaceutical’s Charter of Corporate Conduct.

Response to inquiries

To promote the safe and effective use of drugs, Kyorin Pharmaceutical believes it has a responsibility to respond to inquiries from patients and medical professionals by providing highly reliable drug information that is both fair and impartial. With this understanding, we have established the Drug Information Center to handle various questions. The center responded to around 23,000 inquiries in fiscal 2020.
In responding to inquiries regarding drug information, Kyorin Pharmaceutical is constantly improving with the aim of providing consistent, appropriate and accurate information. This allows us to answer inquiries simply, quickly and accurately, analyze the needs of patients and healthcare professionals, and use them for product lifecycle management. By using the medical information system at the global level, we will respond to inquiries from patients and healthcare professionals with higher quality.

Procurement（SCM）

Initiatives to ensure sustainable procurement

Kyorin Pharmaceutical believes that it is important to fulfill its social responsibilities by optimizing supply chain management, and in order to achieve this, we are requesting our business partners to take measures and cooperate based on their social responsibilities. In addition, in order to achieve sustainable procurement, we will both domestically and internationally comply with relevant laws and regulations, international rules and their spirits, carry out procurement activities with high ethical standards. We also recommend environmentally friendly effort such as using chemical substances in consideration of environmental impact and reducing wastes.

On-site supplier investigations

When selecting a new supplier, we transact 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. For existing suppliers, we make regular visits to preserve and improve product quality and maintain a stable supply. In addition, we conduct risk assessments of work environments (including prevent employee exposure to chemical substances) and take measures to reduce waste and lessen the environmental burden from wastewater and exhaust emissions.
In case we find any items that need to be improved through on-site survey, we propose improvement plans, request a correction plan, and follow up on the 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 (shortwave) 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.

Publishing websites for medical professionals and patients

We strive to meet medical professionals’ needs for information by posting product-related information, the latest academic information, and useful information for day-to-day clinical practice on websites for medical professionals including Kyorin Medical Bridge. We also launched a website for patients in July 2019. This site endeavors to raise patients’ adherence by providing information on the correct ways to take medications and information on illnesses.

Providing ailments information

We create ailment information tools to be used when a medical professional obtains a patient’s informed consent, with the aim of helping patients correctly understand their ailments and improve their quality of life.

Support for the Department of Drug Discovery Medicine

To cultivate innovative human resources for Japan’s drug discovery in the post-genome era through cooperation with industry and academia, we helped establish and provide assistance to the Department of Drug Discovery Medicine at Kyoto University Graduate School of Medicine.

Reliability Assurance

In the wake of quality problems ate generic drugs, including contamination by foreign substances, there is a need to further strengthen and enforce compliance and quality management systems for the manufacture and quality management of ethical drugs. The Kyorin Group believes that it is important to establish an ever-more meticulous reliavility assurance system and to strictly control the quality of the drugs it handles. By promoting initiatives for integrated assurance of reliability of Kyorin products and by delivering high-quality, safe, and secure products to users, we aim to earn the trust of society at large.

Reliability assurance system

Our corporate vision aims to be “a pharmaceutical manufacturer that is trusted by patients and medical professionals, and is recognized for its presence in society.” To achive this, we continuously need to provide products and information that are trusted by broad sectors of society, and we consider this our highest priority. We take a unified approach to all operations?from (research and) development to sales―and place a maximum emphasis on compliance with relevant laws and regulations, and on ensuring reliability. The Quality Assurance & Reliability Division has primary responsibility in this area, and is independent from research and development, manufacturing, and sales divisions, and proactively works to provide products and information that patients and medical professionals can use safely.

Quality assurance

Quality assurance is carried out on investigational new drugs based on GMP at the development stage, through compliance with GMP and GQP after sales, and by confirming that products are manufactured using appropriate equipment and according to designated procedure manuals. After-sales inquiries regarding quality collected from patients and medical professionals are given the highest priority, and are addressed sincerely and quickly.

Safety management

Drugs can be effective for treating patients (benefits) but can have adverse reaction (risks), and side effects that were not foreseen at the developments stage can become apparent after sales. This is why it is important to collect and analyze a wide range of information regarding benefits and risks after a product is launched, and to provide appropriate information swiftly to medical facilities while taking into account the balance between benefits and risks. At KYORIN pharmaceutical Co., Ltd., we strive to ensure safety and promote proper use by carrying out drug-monitoring activities based on GVP. Post-manufacturing surveillance is carried out adhering to GPSP to collect and evaluate information regarding a drug’s safety and effectiveness after the product is launched. The analyzed information is provide to medical professionals and released in professional publicaions.