The Science of Pharmaceutical Regulation

 

Science and Risk-based regulation

  • 藥品核准是基於有力的科學原則 (Sound scientific principle),並應以風險評估 (Risk evaluation)確認其具 備合理的安全及療效。

Regulatory Science

  • Pure science 與 Practical Science (limited by reality)之平衡

  • 適時的審查程序,避免不必要的延遲上市 (undue delay)

  • 適當的審查要求,確保管理的負荷 (regulatory burden)是適當與 負責的 (appropriate and responsible)

  • No perfect answers (evidence-based)

  • Consensus building, common opinion of experts (advisory committee)


Update of Regulation

  • 科技不斷進步,法規亦應不斷更新

  • 審查要求應與科技發展同步

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