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[정책·제도] [국외] FDA, 의약품의 안전성과 품질 강화를 위한 국제 협력 방안지침 마련
  • 부서명 : 기획조정과
  • 작성일 : 2021-05-14
  • 조회수 : 61
  • 출처: FDA

The FDA is continually working to promote drug innovation and improvement, strengthen quality assurance,

safety and supply of drug products and enable more efficient use of industry and regulatory resources.

Through the harmonization of requirements for drug lifecycle management, manufacturers

and the FDA can meet these goals in less time through effective management of postapproval changes.

To help provide a more predictable and efficient approach to management of postapproval changes,

today we’re announcing a final guidance for industry with new International Council for Harmonisation (ICH) guidelines.

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