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Regulatory Affairs Committee

Regulatory Affairs Committee

KRPIA enhances to raise patient accessibility to new drugs by improving regulatory environment and by leading the harmonization of local and global standards

  • Improve the process of new drug approval system and management of post-approval changes.
  • Deliver and voice out the industry’s opinion as a reliable policy partner
  • Lead the local implementation of ICH Guidelines through hosting workshop, training session those are opened to whole industry including local companies
  • Promote the environment and related systems for adopting digital healthcare (ex. e-CTD, e-Labeling, use of RWD/RWE)
  • Timely monitor the regulatory environment and take an appropriate action when needed
  • Improve the New Drug Approval-Patent Linkage System