Various Guidelines

We are committed to act with integrity, complying with laws, regulations and rules.
To be a company that everyone trusts, we practice compliance on a daily basis.

KYORIN Remedio Charter of Corporate Behavior

Businesses are expected to play a role in driving the realization of a sustainable society through the creation of socially beneficial added value and employment and autonomous and responsible actions in the context of fair and free competition.

Generic pharmaceutical companies must contribute to the health, welfare, and medical care of people around the world by developing and supplying quality generic drugs at reasonable prices, and must be a valuable entity that contributes to a sustainable medical insurance system.

As a member of a generic pharmaceutical company, KYORIN Remedio shall act with high ethical standards and comply with relevant laws and regulations, international rules and their spirit, whether in Japan or abroad, based on the following principles of conduct.

Sustainable economic growth and resolution of social issues
To contribute to the efficient allocation of healthcare costs and the health and welfare of the people by providing a stable supply of generic drugs that contribute to a sustainable healthcare insurance system.
Scientific and rigorous research and development
Clinical trials shall be conducted with the cooperation of medical institutions, respecting the human rights of subjects, paying attention to ensuring their safety, and with scientific rigor. In non-clinical studies, necessary animal experiments should be conducted with due consideration for animal welfare. When applying for manufacturing and marketing approval of pharmaceutical products, etc., appropriate handling of data shall be conducted based on relevant laws and regulations, internal rules, etc., and scientific validity.
Promotion of proper use
In order to ensure the proper use of pharmaceutical products, etc., the committee shall accurately provide scientifically supported domestic and foreign information on quality, efficacy and safety, and shall promptly collect, analyze and evaluate post-marketing information and communicate it to the public.
Trusting relationships with medical professionals, patients, etc.
Communicate honestly with medical professionals, patients, and others to improve satisfaction and earn their trust.
Fair Operating Practices
Through fair, transparent, and free competition, we will conduct proper trade and distribution of life-related products, such as pharmaceuticals, as well as responsible procurement. We also maintain healthy relationships with medical professionals, business partners, politics, and government.
Thorough information management
In line with the advanced IT technology, we will give due consideration to the proper protection of personal information, customer information, etc., and take all possible measures for information management.
Fair disclosure and constructive dialogue with stakeholders
Disclose corporate information in a timely, appropriate, and fair manner, and engage in constructive dialogue with healthcare professionals, shareholders, investors, employees, business partners, and local communities surrounding pharmaceutical companies to enhance corporate value.
Reform of work styles and enhancement of work environment
Respect the diversity, personality, and individuality of our employees, while giving due consideration to their health and creating a safe and comfortable work environment. At the same time, the company aims to encourage employees to grow and uplift their sense of ethics, and to manage the company in a way that makes it a rewarding place to work.
Environmental Initiatives
We will act proactively to address environmental issues as a common challenge for all humankind and as an essential requirement for the activities and survival of the company.
Coexistence with society and contribution to social development
As a good corporate citizen, we will actively coexist with society and contribute to its development.
Crisis Management
Thoroughly implement systematic crisis management in preparation for the actions of antisocial forces that threaten the lives of citizens and corporate activities, terrorism, cyber attacks, natural disasters, pandemics, and other such events.
Respect for Human Rights
Management shall respect the human rights of all people.
Management's Role and Enforcement of this Charter
The management recognizes that it is its role to realize the spirit of this Charter, and will take the initiative in thoroughly implementing the Charter, and will encourage its business partners to do so as well. In addition, we will constantly monitor internal and external voices to build effective governance. In the event of a situation that violates the spirit of this Charter and causes a loss of trust from society, management will take the initiative in resolving the problem, investigating the cause and working to prevent recurrence, thereby restoring trust and fulfilling its responsibilities.

Established on September 1, 2006
Revised on April 1, 2023

KYORIN Remedio Co.

Guidelines for Transparency of Relationships between Corporate Activities and Medical Institutions, etc.

Purpose of this Guideline

KYORIN Remedio Co., Ltd. is engaged in the development of pharmaceuticals that contribute to the socialization of medicine, and its corporate purpose is to contribute to the health and welfare of the people by providing a stable supply of high-quality pharmaceuticals, and at the same time to reduce medical costs by providing pharmaceuticals with high medical economic effects, thereby contributing to health and welfare. Our corporate objective is to contribute to health and welfare by providing a stable supply of high quality pharmaceuticals, while at the same time reducing medical costs by providing drugs with high medical economic benefits.

In conducting these activities, we will comply with the Pharmaceutical Affairs Law and other related laws and regulations, as well as the "GE Pharmaceutical Association of Japan Charter of Corporate Behavior," "GE Pharmaceutical Association of Japan Compliance Program Guidelines," "GE Pharmaceutical Association of Japan Code of Practice," "Fair Competition Code for the Ethical Drug Manufacturing and Sales Industry," and other voluntary industry standards established by the Japan Generic Pharmaceutical Association (hereinafter "GE Pharmaceutical Association"). We will comply with voluntary industry standards such as the "GE Pharmaceutical Association Compliance Program Guidelines," the "GE Pharmaceutical Association Code of Practice," and the "Fair Competition Code for the Prescription Pharmaceutical Manufacturing and Sales Industry," as well as our own Charter of Corporate Behavior, and strive to maintain sound relationships with medical institutions and healthcare professionals.

These guidelines are based on the GE Pharmaceutical Association's "Transparency Guidelines for Relationships between Corporate Activities and Medical Institutions," and are intended to ensure transparency in relationships with medical institutions, etc., so that the pharmaceutical industry can contribute to the development of life sciences, including medical and pharmaceutical sciences, and that corporate activities are conducted with a high level of ethical standards The objective is to gain a broad understanding of the pharmaceutical industry's contribution to the development of life sciences, including medicine and pharmaceuticals, and that corporate activities are conducted with high ethical standards.

basic policy

A company must be an economic entity that pursues profit through fair competition, and at the same time, it must be useful to society at large.

As a member of the pharmaceutical industry, KYORIN Rimedio Corporation (hereinafter referred to as "the Company") is committed to "fulfilling our social mission to contribute to people's health through a spirit of compassion for life. Under the corporate philosophy of the KYORIN Group, "We will respect human rights, comply with all laws, regulations, codes of conduct, and their spirit, and act with high ethical standards, regardless of national or international borders.

In all of our activities, we will comply with the Pharmaceutical Affairs Law and other related laws and regulations, voluntary industry standards, and our own Charter of Corporate Behavior, and in the spirit of these standards, we will ensure transparency in our relationships with medical institutions and fulfill our mission to society.

Publication Method

Funding for medical institutions, etc. will be disclosed through the company website and other means after the close of the fiscal year.

Open to the public

The information will be disclosed within one year after the end of each fiscal year of the Company.

Disclosure Policy

A. Research and development expenses, etc.

Research and development expenses, etc., include expenses incurred for research and investigations conducted under public regulations such as the Clinical Research Act and the GCP/GVP/GPSP Ministerial Ordinance in the Pharmaceuticals and Medical Devices Act, as well as various guidelines.

B. Academic Research Grants

Scholarship donations and general donations made for the purpose of promoting academic research and subsidizing research, etc., as well as donations to academic societies, etc., to support the costs of holding meetings of academic societies, etc., and expenses for co-sponsoring academic societies, etc.
The "co-sponsorship fees for conferences, etc." include co-sponsorship fees for seminars, etc., advertising fees, and exhibition fees associated with the holding of the meeting.

C. Manuscript writing fees, etc.

Expenses, etc., paid for the provision of scientific information, etc., on medical and pharmaceutical sciences, including the company's own pharmaceutical products, or for outsourcing services such as lectures, manuscript writing, supervision, and other consulting services related to research and development.

D. Information provision-related expenses

Expenses for lectures, information meetings, etc., to provide information, etc., on the company's pharmaceuticals and medical and pharmaceutical sciences to medical professionals.

E. Other Expenses

Expenses such as hospitality as a social ritual.

notes

The amounts for each item are calculated based on the Company's accounting year (April 1 of each year through March 31 of the following year).
Data that may contain personal information will be handled appropriately in accordance with our Privacy Policy.
Unauthorized reproduction or reprinting of the contents of the PDF file is prohibited.
Downloading PDF files is not permitted.
PDF files are set to non-printable.

Payments to medical institutions and healthcare professionals

Disclosure on Directors Responsible for Pharmaceutical Affairs, etc.

The following information, which is important for proper business activities, is disclosed.

Responsible officers and division of duties related to pharmaceutical affairs

post	Name of board member	R & D	pharmaceutical affairs	Quality Assurance (GQP)	Safety Management (GVP)	Manufacturing (GMP)	advertisement	Compliance	Pharmaceutical Sales
President and Representative Director	Hiroshi Hashizume	period	period	period	period	period	period	period	period
board member	Yuji Fujii						period	period	period
board member	Shuji Itabashi		period	period	period	period

Three roles in the manufacturer and distributor of pharmaceutical products

Chief Marketing Authorization Holder for Drugs, etc.	Eimiko Urakami
Quality Assurance Manager for Pharmaceuticals, etc.	Masashi Seto
Person in Charge of Safety Management of Drugs and Other Drugs	Makiko Iwamura

Declaration of Compliance with Laws and Regulations

We recognize that the recent problems related to the quality and safety of generic drugs are extremely serious issues that have greatly shaken confidence not only in generic drugs but also in pharmaceuticals as a whole.

Pharmaceutical products are used to treat patients' diseases and are directly related to their lives. Inappropriate quality and safety management in violation of laws and regulations can lead to serious health hazards.

We are committed to the corporate philosophy of the KYORIN Group, "KYORIN will carry out its social mission to contribute to the health of people through a spirit of compassion for life. We are aiming to be a "Trusted Pharmaceutical Company" under the "Pharmaceutical Company Law of Japan.

In order to deliver safe and reliable generic drugs to patients, we, the President and Representative Director, as well as all executives and employees, hereby declare that we have a strong awareness of legal compliance and will work together as a company to conduct our business.

November 30, 2021

KYORIN Remedio Co.
Hiroshi Hashizume, President and Representative Director