ICH Guideline Q6A: Test Procedures and Acceptance Criteria
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Questions and Answers

What is the purpose of the ICH Harmonised Tripartite Guideline?

  • To regulate the marketing of pharmaceuticals for human use
  • To conduct clinical trials for new drug substances
  • To provide specifications for new drug substances and products (correct)
  • To oversee the patenting process for new drugs
  • What is the significance of reaching Step 4 of the ICH Process?

  • The guideline is approved for marketing in the European Union, Japan, and USA
  • The final draft is recommended for adoption to regulatory bodies (correct)
  • The guideline is released for public consultation
  • The ICH Steering Committee approves the guideline
  • What does the ICH Guideline specify?

  • Regulatory requirements for drug import and export
  • Test procedures and acceptance criteria for new drug substances and products (correct)
  • Marketing strategies for pharmaceutical companies
  • Clinical trial protocols for new drugs
  • What is the purpose of the ICH Process?

    <p>To recommend drug substances for adoption to regulatory bodies</p> Signup and view all the answers

    What happens at Step 2 of the ICH Process?

    <p>Approval by the Steering Committee and release for public consultation</p> Signup and view all the answers

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