KOR/713
WTO/TBT
KR South Korea
  • 11 - Health care technology
2017-06-12
2017-04-13
Biological Products

Proposed amendments to the "Regulation on Approval and Review of Biological Products" (21 pages, available in Korean)

•  To ensure prompt and predicable biopharmaceutical product approval procedure, introduce the pre-review system for expedited review to check whether requirements for product approval are met or not.

•  Required information such as clinical trial report, pharmacokinetics and etc. should be provided to medical doctors and pharmacists so that they (expert) make informed diagnosis and prescription.

•  Establish regulation regarding mandatory informed consent provision for cell donors when cells are collected for manufacture of cell therapy products and gene therapy products.