The following guideline is a revised version of the ICH Q1A guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a registration …

The envisioned result is a combined guideline, ICH Q1, with integrated annexes and/or appendices that address specific topics beyond the core stability recommendations and …

This document defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the ICH regions. It does not cover the information …

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...

ICH Q6A and Q6B should be consulted for recommendations on the setting and justification of acceptance criteria, and ICH Q1D should be referenced for recommendations on the use of …

Further guidance on new dosage forms and on biotechnological/biological products can be found in ICH guidances Q1C Stability Testing for New Dosage Forms and Q5C Quality of …

Training materials developed by ICH Working Groups, ICH Training Associates and external Training Providers can be found in the below Training Library and under respective ICH …

seeks to exemplify the core stability data package required for new drug substances and products. It is not always necessar. an analysis of the effects of climatic conditions in the three …

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as a Tier 1 guideline, ICH Q5C, and the WHO stability guidance covering Climatic Zones III and IV (i.e., content of the withdrawn ICH Q1F) are implemented …

This revised ICH guidelines regulate the scope necessary for marketing authorization of the stability testing of new active substances and finished medicinal products containing new …