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  • China's "New Law" tightens safety and quality management
  • by Kim, Jung-Ju | translator Byun Kyung A | Jan 8, 2020 06:15am
Regulation tightens specifically for clinical institute, GMP and GSP and illegal practices
China is to reinforce overall pharmaceutical management and monitoring regulation covering from pharmaceutical production, launch, clinical trial to counterfeit drug. The so-called ¡®New Drug Administration Law¡¯ would mainly focus on safety and quality.

China¡¯s National Medical Products Administration (NMPA) had taken the revised law in effect from last month. Considering the time it needs to settle in with the entire system, the new law would be enforced from the beginning of this year.

The revision consists of pharmaceutical marketing authorization holder system, clinical trial institute record management, Good Manufacturing Practice (GMP) and Good Storage Practice (GSP) management, review and approval on
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