[E-Daily Reporter Kim Seung-kwon ] Yuhan(000100)operates a world-class research management system that prioritizes bioethics and the safety of research participants throughout the entire new drug development process. The company plans to strengthen a culture of responsible research throughout the entire research and development (R&D) process by designing clinical trials in accordance with international standards and ensuring that animal experiments undergo review by an ethics committee and post-experiment monitoring.

On the 8th, Yuhan Corporation announced that it has established and is operating an experimental ethics and safety management system that complies with global standards throughout the entire new drug development process, from clinical trials to preclinical research.

The company places the rights and safety of clinical trial participants as its top priority and conducts all clinical trials only after obtaining prior approval from domestic and international regulatory agencies and Institutional Review Boards (IRBs). Clinical trial protocols are established based on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and the World Medical Association (WMA) Declaration of Helsinki, and the company ensures strict compliance with relevant regulations throughout the research process.

Once a clinical trial begins, the company works closely with investigators to continuously monitor adverse events. It regularly reviews safety data through the Safety Review Committee (SRC) and Medical Review Meetings (MRM), and has a system in place to promptly report any serious adverse events to regulatory agencies and ethics review boards in accordance with relevant laws and procedures.

Safeguards for participant protection have also been put in place. Yuhan has taken out clinical trial liability insurance to establish a safety net ensuring that research participants receive appropriate treatment and compensation in the event of unexpected side effects or accidents.

The company emphasized that it applies strict ethical standards based on the principle of respect for life even during animal testing. Yuhan Corporation operates an Institutional Animal Care and Use Committee (IACUC) composed of three in-house veterinarians and two external members, which reviews the necessity and ethical soundness of all animal testing plans in advance.

Through regular meetings, the committee reviews the results of its deliberations and the status of research implementation. It also conducts Post-Approval Monitoring (PAM) to continuously verify that experiments are proceeding according to the approved protocols. This process ensures that ethical standards are properly adhered to throughout the research process and identifies areas for improvement.

The company also applies the internationally recognized “3R Principles” in its animal testing operations. The 3R Principles refer to: △ Replacement—substituting laboratory animals with alternative testing methods; △ Reduction—using only the minimum number of animals necessary; and △ Refinement—minimizing animal pain and stress during the experimental process.

Yuhan Corporation explained that it has established systematic guidelines covering the entire process—including standards for the import and handling of animals, as well as the management of their housing environments—to minimize the unnecessary use of animals and ensure both the reliability and ethical integrity of its research.

Recently, in the global pharmaceutical industry, expectations have been rising not only for research outcomes but also for research ethics, sustainability (ESG) management, and animal welfare during the new drug development process. Major regulatory agencies are also continuously refining relevant standards to strengthen the protection of clinical trial participants and research transparency, thereby increasing the importance of ethical management for pharmaceutical companies.

A Yuhan Corporation official stated, “The foundation of new drug development must be based not only on promoting human health but also on respect for life and a strict sense of ethics throughout the research process,” adding, “We will continue to lead a culture of responsible research by adhering to the highest global standards of laboratory ethics throughout the entire R&D process and giving equal consideration to the safety of participants and animal welfare.”