ICH guidelines Q12, E9(R1) and M9 adopted following assembly in Singapore

International Council for Harmonisation (ICH) updated on the Milestones achieved following their assembly in Singapore. A few guidelines for Step 4 of the ICH process were adopted to promote innovation alongside continual improvement in the pharmaceutical sector and to strengthen quality assurance and reliable supply of  products. They include:

  • Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
  • E9 (R1): Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses
  • M9: Biopharmaceutics Classification

Concept papers and business plans for the 6 new topics mentioned were also finalized:

  • E6 (R3): Good Clinical Practice.
  • E2D (R1): Post Approval Safety Data Management
  • E20: Adaptive Clinical Trial
  • Q5A (R2): Viral Safety Evaluation of biotechnology Products.
  • S12: Nonclinical Bio distribution. Studies for Gene Therapy Products.
  • M12: Drug Interaction Studies.

2 Concept papers outline discussed previously were also approved during this assembly:

  • M13: Bioequivalence for Immediate-Release Solid Oral Dosage Forms.
  • Q9: Guideline on Quality Risk Management.



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