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Toxicological Assessment

Safety Assessment

Background

  • To develop safety and efficacy assessment methods based on new technologies to shorten the new drug development period and ensure the development of safer medicinal products
  • To introduce toxicological assessment methods and establish infrastructures in order to proactively respond to changes in OECD and ICH guidelines
  • To take into account the development of innovative clinical assessment techniques in advanced countries to shorten the pharmaceutical development period
  • To take into account new customized drug development technology and genome information utilization technology selected as strategic technology for realization of people's health and longevity, as one of the five key national technology fields
  • To improve the review of studies on human subjects and studies on materials of human origin in terms of scientific and ethical aspects and reinforce training of researchers in ethics
  • To develop an information system to provide toxicological information directly relating to the safety of medicinal products
  • To promptly regulate new psychoactive substances arising from the increased introduction of such substances
  • To develop standardized methods and criteria for the screening of narcotics users

Key activities

  • Development of drug assessment methods based on new technologies, such as "omics"
  • Improvement of toxicological study procedures to advance safety assessment
  • Safety pharmacology and interaction of medicinal products
  • Assessment of clinical studies and supports for safety control of medicinal products
  • Development of foundation for commercialization of personalized medicinal products
  • Operation of institutional review board in the National Institute of Food and Drug Safety Evaluation
  • Operation of toxicological information service system (Tox-Info)
  • Establishment of database system for control of information on high-risk toxicological substances and related diseases
  • Establishment of clinical database system for performance and assessment of clinical studies
  • Assessment of new psychoactive substances' dependency and hazards
  • Development of guidelines on examination of narcotics users
R&D
Establishment of a system for safety prediction and assessment of potentially hazardous substances through toxicological, pharmacological, clinical and animal studies, in order to provide scientific rationales for the development of policies for safety control of food and medicinal products
1 National control of toxicological substances
  • Toxicological investigation of potentially hazardous substances and the development of a technical foundation for toxicological assessment of nanomaterials
2 Drugs’ safety prediction and assessment
  • Studies on the development of technologies for review and assessment of the quality, safety and efficacy of medical products
3 Development of a technical foundation for clinical study and assessment of Korean subjects
  • Studies to protect people using medical products
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