ICH Guideline Q6A: Test Procedures and Acceptance Criteria

• 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

• 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

• 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

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

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