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.