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 application within the three regions of the EC, Japan, and the United

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...

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 to be submitted for abbreviated or abridged applications, variations and clinical trial applications.

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: Streamlining the series, combining the various guidelines into a single guideline focused on core stability principles;

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...

本注释的目的是概述这个指导原则相对Q1A（R）的变化，这些变化是因采纳了ICH Q1F,即“在气候带Ⅲ和Ⅳ地区注册申请的稳定性研究要求”这一指导原则而产生的相关内容，内容包括： 中间放置条件可从30℃±2℃/60%RH±5%RH切换为30℃±2℃/65%RH±5%RH，但必须清楚记录切换前后的放置条件和切换日期并在注册申请中阐明。 在本修订的指导原则出版三年后，建议在ICH三地 …

CPMP/ICH/380/95 1/13 STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS ICH Harmonised Tripartite Guideline [EMEA Status as of December 1993] Preamble The following guideline sets out the stability testing requirement for a Registration Application within the three areas of the EC, Japan and the USA. It does not seek necessarily

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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 …

ICH Q1A(R2) categorizes stability testing into three primary types: Long-Term Testing: Conducted under recommended storage conditions to evaluate shelf life. Accelerated Testing: Performed under harsher conditions to simulate long-term storage effects in a shorter timeframe.