Yuhan Corporation Implements Experimental Ethics and Safety Management System Aligned with Global Standards

Applying Bioethics Principles Throughout New Drug Development
Clinical Trial Design Based on ICH Guidelines and the Declaration of Helsinki
Operation of IACUC and Adherence to the 3Rs Principle

Yuhan Corporation announced on July 8 that it operates an experimental ethics and safety management system aligned with global standards, in order to uphold bioethics throughout the entire new drug development process and ensure the safety of research participants.

Yuhan Corporation Headquarters Exterior. Yuhan Corporation

The company places the rights and safety of clinical trial participants as its top priority, conducting all clinical trials only after obtaining prior approval from domestic and international regulatory authorities and Institutional Review Boards (IRBs). Clinical trial protocols are established in accordance with the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Declaration of Helsinki of the World Medical Association.

Adverse events that may occur during clinical trials are continuously monitored in collaboration with researchers. Safety data are regularly reviewed by the Safety Review Committee (SRC) and Medical Review Meeting (MRM). In the event of any adverse case, the company has established a system to report it to regulatory authorities and ethics committees within the stipulated timeframe. In addition, by subscribing to clinical trial liability insurance, Yuhan Corporation ensures that participants can receive necessary treatment and compensation even in unforeseen circumstances.

Ethical standards based on respect for life are also applied to animal testing. Yuhan Corporation operates an Institutional Animal Care and Use Committee (IACUC) composed of three internal veterinarians and two outside members, which reviews the necessity and ethical justification of experiments in advance.

The committee holds regular meetings to review the results and details of deliberations, and conducts post-approval monitoring (PAM) of experiments to ensure procedural appropriateness. Furthermore, the company operates guidelines on the import and handling of animals and their breeding environments, and applies the 3Rs (Replacement, Reduction, and Refinement) principle to minimize unnecessary animal use.

A Yuhan Corporation official stated, "The foundation of new drug development requires not only the enhancement of human health but also respect for life and a strict ethical mindset throughout the research process," adding, "We will continue to lead a responsible research culture by adhering to the highest global standards of experimental ethics throughout all stages of research and development."

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