---
title: "ICH Draft Q3E Guideline on Extractables & Leachables Now Open for Consultation"
description: "The International Council for Harmonization (ICH) has advanced the long-anticipated Guideline for Extractables and Leachables (Q3E) to Step 2b, initiating the global public consultation phase."
url: https://qbdgroup.com/en/regulatory-updates/ich-draft-q3e-guideline-now-open-for-consultation
type: "Regulatory update"
language: en
published: 2025-08-13
author: "Javier López, Toxicology Expert"
category: "Regulatory Affairs"
publisher: "QbD Group"
citation: "QbD Group, \"ICH Draft Q3E Guideline on Extractables & Leachables Now Open for Consultation\", https://qbdgroup.com/en/regulatory-updates/ich-draft-q3e-guideline-now-open-for-consultation"
---
# ICH Draft Q3E Guideline on Extractables & Leachables Now Open for Consultation
> The International Council for Harmonization (ICH) has advanced the long-anticipated Guideline for Extractables and Leachables (Q3E) to Step 2b, initiating the global public consultation phase.

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

### Scientific Justification

Applications must include a clear, science-based rationale for conducting E&L studies, supported by product and risk specific considerations.

### Holistic Risk Management

The guideline outlines a lifecycle-based approach integrating _Risk Assessment, Risk Control, and Risk Review_, in alignment with ICH Q9 principles.

### Comprehensive Technical Appendices

Six detailed annexes provide guidance on topics such as study types, Analytical Evaluation Threshold (AET) calculations, potency-based classification of leachables, exposure limit derivation, and Class 1 leachable monographs.

## 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.

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## Extractables & Leachables Reports that ensure your product’s safety

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Source: https://qbdgroup.com/en/regulatory-updates/ich-draft-q3e-guideline-now-open-for-consultation — © QbD Group. Quote freely with attribution and a link back.