πŸ‡°πŸ‡·Ministry of Food and Drug Safety

MFDS NAMs Framework

South Korea's MFDS is implementing progressive NAMs pilot programs with strong domestic organ-on-chip industry and KoVAM validation center.

Pilot
Active Programs
KoVAM
Validation Center
2025
Framework
ICH
Member
Written by J Radler | Patient Analog
Last updated: January 2025

Regulatory Highlights

  • Current regulatory framework and acceptance pathways
  • Compliance requirements for NAMs submissions
  • International harmonization through ICH guidelines
  • Practical guidance for regulatory strategy

Korea's NAMs Regulatory Development

South Korea is rapidly developing its NAMs regulatory framework, driven by a strong domestic organ-on-chip industry and government support for innovative pharmaceutical technologies.

KoVAM Validation Center

The Korean Center for the Validation of Alternative Methods (KoVAM) validates NAMs against OECD test guidelines and develops Korea-specific acceptance criteria.

  • OECD Alignment: Validates NAMs against international standards
  • Industry Support: Assists companies in NAMs validation
  • International Cooperation: Partners with ICCVAM, JaCVAM, EURL-ECVAM