ICH Draft Q3E Guideline on Extractables & Leachables Now Open for Consultation

This milestone represents a decisive step toward harmonizing international requirements for the assessment and control of leachables in pharmaceuticals, addressing a critical regulatory gap that has historically led to variability and ambiguity across regions.

Key Regulatory Expectations for Sponsors

Why This Guideline Is a Game-Changer

• Closes a long-standing gap 
  For the first time, a unified framework will exist for leachable risk assessment across oral, parenteral, ophthalmic, and advanced modalities, including cell and gene therapies
• Strengthens risk-based decision making 
  By linking chemical characterization with toxicological evaluation, the guideline enables sponsors to focus on leachables that are relevant to patient safety, optimizing resources and timelines.
• Regulatory alignment 
  Harmonization will reduce redundant testing and conflicting expectations, streamlining global submissions and inspections
  
  

Strategic Implications for Industry

• Stakeholders are urged to review and comment on the public draft before the consultation closes at the end of 2025.
• With final adoption anticipated post-2027, organizations should begin aligning internal SOPs, vendor qualification processes, and risk assessment methodologies to Q3E principles.
• Early familiarity with the technical annexes will accelerate study design, supplier negotiations, and toxicological evaluations.
  
  

The bottom line

The draft ICH Q3E represents a paradigm shift: moving E&L control from a fragmented, product-type-specific exercise to a globally harmonized, science-driven, lifecycle-based process. For companies, it is both a compliance imperative and a strategic opportunity to enhance efficiency, regulatory confidence, and ultimately patient safety.