KOR/1067
WTO/TBT
KR South Korea
  • 30 - Pharmaceutical products
2022-06-18
2022-04-21

Pharmaceuticals

Regulation on Safety of Pharmaceuticals, etc.; (28 page(s), in Korean)

To reinforce post marketing safety management and streamline submission of use of investigational products for treatment purpose by establishing legal basis on order to change of submission deadline of pharmaceutical risk management plan and on safety and efficacy review results. And to ensure patients' safety in using the investigational products by obligating investigational products providers to manage the safety information.