Requirements for Drug Approval


療效與安全性相關資料 (Safety, Efficacy)

  • 藥/毒理 (Pharm/Tox): Drug substance, excipients

  • 藥物動力學 (PK/PD/BA): Drug substance, pilot formulations

  • 臨床試驗

      ⇨ Phase I & II clinical trials: Drug substance, pilot formulations

      ⇨Phase III clinical trials: Pivotal clinical formulation (exhibition batch)

  • 銜接性試驗評估

  • 生體相等性試驗 (BE): Drug products

      ⇨Marketed formulation

      ⇨Generic drug products

      ⇨Post-approval changes for both brand and generic drug products

品質相關資料 (Quality)

  • Chemistry, Manufacturing and Controls (CMC)

      ⇨Quality-Raw materials, drug substance, excipients, drug product, container/closure, equipment, process, specifications, release, stability

      ⇨Demostrate manufacturing capacity

      ⇨Validation, specifications, controls, scale up, PAI

  • Direction of use (Labeling)

  • Data integrity and honest communication

     ⇨ PAI-cGMP, GLP, GCP audit

  • Continue to commit to product quality and performance

     ⇨ Post-approval commitments and post-marketing monitoring