Difference Between ICH and ISO Guidelines



  • ICH stands for: International conference on harmonization of technical requirements for registration of pharmaceuticals for human use.
  • ISO stands for: International oraganization for standardization.


  • ICH primarily focused on pharmaceutical and biopharmaceutical industry.
  • ISO cover broad range of industries including medicinal, food, and others.

  • ICH developed through the collaboration of regulatory authorities and pharmaceutical industries.
  • ISO developed through the technical committees.

  • ICH concentrates on technical and scientific aspects of pharmaceutical product development and registration.
  • ISO covers various management system, processes, and requirements.

  • Often mandatory for regulatory compliance in countries participating in ICH.
  • ISO can be adopted voluntary by organizations.

  • ICH romote global harmonization of technical requirements for pharmaceuticals.
  • ISO may vary across countries due to national adoption.

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