About the Center for Safety Research

The Center for Safety Research at the Biomedical Research Institute (BRI), Seoul National University Hospital (SNUH), is an institution specializing in nonclinical safety and efficacy evaluation across a wide range of fields, including pharmaceuticals, medical devices, cosmetics, quasi-drugs, and health functional foods.

In 2003, it became the first university hospital in Korea to be designated by the Ministry of Food and Drug Safety as a testing facility compliant with Good Laboratory Practice (GLP) for nonclinical studies. Since then, through continuous quality management and capacity building, it has provided highly reliable test data. It has also been designated as a state-accredited medical device testing and inspection institution by the Ministry of Food and Drug Safety, performing biological safety and efficacy evaluations for medical device product approval and supporting domestic and international licensing.

In particular, by establishing a Nonclinical-to-Clinical ONE-STOP SYSTEM linked with the Clinical Trials Center, it provides an integrated evaluation framework spanning the entire development process and approval procedures, from nonclinical studies through clinical trials. This effectively supports shorter development timelines and the establishment of successful licensing strategies.

Four Core Values

Throughout the testing process, we comply with GLP regulations and operate a Scientific Committee with field-specific expertise to produce high-quality data that secures the following four core values.

Speciality

Reliability

Accuracy

Reproducibility


Building on these capabilities, we support the development of new drugs, medical devices, cosmetic ingredients, and food ingredients, with the ultimate goal of contributing to human health and a better quality of life.

Key Designation and Accreditation History

2020
  • Designated by the Ministry of Food and Drug Safety as Medical Device Nonclinical Testing Facility No. 11
2012
  • Designated by the Ministry of Food and Drug Safety as Excellent Animal Testing Facility No. 1
2007
  • Accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC)
2003
  • Designated by the Ministry of Food and Drug Safety as Pharmaceuticals Nonclinical Testing Facility No. 10
2000
  • Designated by the Ministry of Food and Drug Safety as Medical Device Testing and Inspection Institution No. 4

Center for Safety Research Organization Chart

Center for Safety Research organization chart Organizational structure of the Center for Safety Research, comprising five teams and direct departments under the Operations Director. The Scientific Committee is positioned on the left, while the Quality Assurance Team, Archive and Specimen Management, and Research Support are placed directly on the right. Five teams (Safety Evaluation Team, Clinical Pathology Team, Histopathology Team, Analytical Chemistry Team, Laboratory Animal Management Team) report to the Operations Director; the Safety Evaluation Team is subdivided into five areas and the Laboratory Animal Management Team into four areas. Operations Director ScientificCommittee Quality Assurance Team Archive & Specimen Mgmt Research Support Safety EvaluationTeam Clinical PathologyTeam HistopathologyTeam AnalyticalChemistry Team Lab Animal MgmtTeam GeneralToxicology SpecialToxicology GeneticToxicology EfficacyEvaluation Test SubstanceMgmt &Formulation Rodents Rabbits, Medium& Large Animals Primates QC