ICH: New Guideline for Stabilities

The draft guideline "STABILITY TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTS" of the ICH (INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE) was published in April 2025 and is now open for public comment. Comments are possible until the end of July 2025, with some exceptions specifically indicated on the ICH website.

This new version is intended to merge and replace the previous individual ICH guidelines (ICH Q1A-Q1F and ICH Q5C) in the area of stabilities. It will apply to active substances and finished drug products and takes into account new scientific and risk-based approaches and technologies. The table of contents can be summarised in the following points and annexes:

1 INTRODUCTION
2 DEVELOPMENT STABILITY STUDIES UNDER STRESS AND FORCED CONDITIONS
3 PROTOCOL DESIGN FOR FORMAL STABILITY STUDIES
4 SELECTION OF BATCHES
5 CONTAINER CLOSURE SYSTEM
6 TESTING FREQUENCY
7 STORAGE CONDITIONS
8 PHOTOSTABILITY
9 STABILITY CONSIDERATIONS FOR PROCESSING AND HOLDING TIMES FOR INTERMEDIATES
10 SHORT-TERM STORAGE CONDITIONS
11 IN-USE STABILITY
12 REFERENCE MATERIALS, NOVEL EXCIPIENTS AND ADJUVANTS
13 DATA EVALUATION
14 LABELLING
15 STABILITY CONSIDERATIONS FOR COMMITMENTS AND PRODUCT LIFECYCLE MANAGEMENT
16 GLOSSARY
17 REFERENCES
18 ANNEXES
ANNEX 1 REDUCED STABILITY PROTOCOL DESIGN
ANNEX 2 STABILITY MODELLING
ANNEX 3 STABILITY OF ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPS)

Chapters 1, 2, 3, 4, 7, 8, 9, 11, 12, 13, 14 and 15 each have one or more detailed subsections.

The complete draft of the guideline "STABILITY TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTS", the business plan and the concept paper as well as the work plan for this can be viewed on the ICH website under the "Public Consultations" tab. Under the "WG Presentation/Trainings" tab, you will also find instructions for commenting, which also contain a summary of the guideline.