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  • Integrating PMS with RMP to protect new drug information
  • by Lee, Tak-Sun | translator Byun Kyung A | Jul 20, 2020 06:19am
MFDS to gradually implement changes in post-marketing safety management system by 2022
The post-marketing surveillance (PMS) system that monitors new drug¡¯s adverse reaction experienced by patients to maintain the drug safety would be integrated with the risk management plan (RMP) review system.

The number of investigated subjects would be reasonably adjusted and the data protection system for the authorized new drug would be created separately.

On July 16, Korea¡¯s Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-kyung) announced a plan to revise the post-marketing drug safety management system that mainly focuses on integrating the current PMS with RMP, which aims to manage a drug safety in all lifecycle.

Implemented from 1995, Korea¡¯s PMS reevaluates safety and efficacy of new
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