R&D Ethics

Ethical considerations for the use of animals in experiments

Animal experiments are essential in the research and development of drug to promote human health.

ビットカジノompany 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 ビットカジノonduct 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 ビットカジノonditions 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 ビットカジノontents 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.

ビットカジノommittee 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 ビットカジノonvention 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 ビットカジノartagena Protocol and regulations to conserve biodiversity, give consideration to ethics and handle it carefully.

Respect for subjects’ human rights, security of personal information, and maintenance of trust during ビットカジノs

The Company carries out ビットカジノs in line with the Declaration of Helsinki and relevant laws and regulations governing ビットカジノs 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.

ビットカジノ plans are approved after inspection for ethicality and scientific validity by internal and external committees.

Moreover, ビットカジノs are carried out after the subjects are fully informed about items including the objectives of ビットカジノs 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 ビットカジノs receive education and training, and ビットカジノ institutions are monitored to ensure that the ビットカジノs are appropriately carried out in compliance with GCP.

The Company also strives to manage ビットカジノ data properly to ensure that the subjects’ privacy is protected. In addition, it regularly confirms that ビットカジノs done externally are carried out in conformity with the same standards.

Disclosure of information related to ビットカジノs and trial results

We are working to improve transparency by disclosing ビットカジノ plans and results.

Plans for ビットカジノs led by Kyorin are posted on a ビットカジノ database available to the general public. Going forward, we will create an environment that allows appropriate access to ビットカジノ data by researchers and others who might use that data, discloses information to maximize the value of ビットカジノ data, and plays roles in advancing science and promoting innovation.

We are currently considering methods for information disclosure.

Policies for the disclosure of ビットカジノ data will be released as they are finalized.

Increased access to investigational new drugs

Some patients with serious or life-threatening diseases have tried all the treatments currently available to no effect but are unable to receive treatment with investigational new drugs because they are ineligible to participate in ビットカジノs.

Taking into account patients who wish to receive investigational new drugs but are unable, for various reasons, to do so, from a humanitarian perspective we have formulated a “rule on the request for an extended ビットカジノ” that lays out the procedure for providing investigational new drugs to patients when requested by a medical institution for reasons other than ビットカジノs or by a regulatory authority.

Handling of intellectual property

Appropriate protection of intellectual property is important for maintaining competitiveness while meeting unmet medical needs, and we have formulated internal guidelines for handling intellectual property.

In research and development, we are working proactively to protect intellectual property and concentrating our investment in acquiring intellectual property rights to create an intellectual property portfolio that contributes to business continuity.

We are also emphasizing IP (intellectual property) landscape activities based on an analysis of patent information to share intellectual property information with research divisions and help build a research and development pipeline for the future.