This document explains the withdrawal of ICH guideline Q1F from ICH website. Keywords: Stability, climatic zones, ICH Q1F, withdrawal, ICH Q1A (R2) Current effective version

Further to the ICH Management Committee’s endorsement of the Q1/Q5C Concept Paper and Business Plan in November 2022, the Q1/Q5C EWG was established to revise the current ICH Stability Guideline Series Q1A-F and Q5C by:

ICH Q1 F described harmonised global stability testing requirements in order to facilitate access to medicines by reducing the number of diferent storage conditions.

This guideline describes an approach to broader use of the ICH guideline “Q1A(R) Stability Testing of New Drug Substances and Products” (hereafter referred to as the parent guideline) and outlines the stability data package for a new drug substance or drug product that is

Due to this divergence in global stability testing requirements, the ICH Steering Committee has decided to withdraw ICH Q1F and to leave definition of storage conditions in Climatic Zones III and IV to the respective regions and WHO.

ICH Q1 F described harmonised global stability testing requirements in order to facilitate access to medicines by reducing the number of different storage conditions.

ICH Q1C Stability testing: requirements for new dosage forms; ICH Q1D Bracketing and matrixing designs for stability testing of drug substances and drug products - Scientific guideline; ICH Q1E Evaluation of stability data; ICH Q1F Stability data package …

The purpose of this revision is to harmonize the intermediate storage condition for zones I and II with the long-term condition for zones III and IV recommended in the ICH guidance Q1F Stability...

This guidance document describes an approach for the broader use of the ICH guidance document Q1A(R) - Stability Testing of New Drug Substances and Products by outlining the stability data package for a new drug substance or drug product that is considered sufficient for a registration application in territories in Climatic Zones III and IV2.

The ICH Q1 series (Q1A-Q1E) as a Tier 1 guideline, ICH Q5C, and the WHO stability guidance covering Climatic Zones III and IV (i.e., content of the withdrawn ICH Q1F) are implemented successfully in the regulatory framework by most regulatory authorities.