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  • New pharmaceutical data protection system begins
  • by Lee, Jeong-Hwan | translator Kim, Jung-Ju | Oct 4, 2023 05:35am
Strengthening IMDs¡¯ monopoly rights
Integrated operation of post-marketing safety management and risk management system
Representative Jeon Hye-sook's representative motion, "Improvement of pharmaceutical industry research and development capabilities"
Legislation is being promoted to abolish the drug reexamination system, establish a separate legal basis for the drug data protection system, encourage research and development in the pharmaceutical industry, and strengthen the monopoly on the IMDs market. It also includes provisions to reduce the burden on pharmaceutical companies due to the reexamination system and overlapping operations by integrating the drug post-marketing safety management system into the risk management system.

On the 3rd, Jeon Hye-sook, a member of the Democratic Party of Korea, announced that she had proposed a partial amendment to the Pharmaceutical Affairs Act to this effect. The Ministry of Food and Drug Safety has been insisting on th
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