ICH Guidelines - Summary
ICH Guideline PDF offers essential recommendations on stability testing protocols, including factors like temperature, humidity, and trial duration specifically for Climatic Zones I and II. The updated document now also considers the stability testing requirements for Climatic Zones III and IV, helping to minimize various storage conditions needed for a global dossier submission.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) plays a crucial role in uniting regulatory authorities and the pharmaceutical industry to talk about scientific and technical aspects of drug registration. The ICH Guideline is developed by a qualified ICH Expert Working Group and undergoes consultations by regulatory parties as per the ICH Process. In Step 4, the final draft is recommended for adoption by the regulatory bodies in the European Union, Japan, and the USA.
Understanding ICH Guidelines
- Quality Guidelines: The harmonisation achievements in the Quality area include major milestones such as conducting stability studies, establishing relevant thresholds for impurities testing, and adopting a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management. To access the Quality Guidelines in PDF.
- Safety Guidelines: ICH has developed a thorough set of safety guidelines to identify potential risks like carcinogenicity, genotoxicity, and reprotoxicity. A recent advancement includes a non-clinical testing strategy for evaluating the QT interval prolongation liability, which is a key reason for drug withdrawals in recent years.
- Efficacy Guidelines: ICH’s work under the Efficacy category focuses on the design, conduct, safety, and reporting of clinical trials. It also addresses new types of medicines developed from biotechnological processes and the application of pharmacogenetics/genomics techniques for creating better-targeted medicines.
- Multidisciplinary Guidelines: These guidelines cover topics that span across Quality, Safety, and Efficacy categories. They include the ICH medical terminology (MedDRA), the Common Technical Document (CTD), and the creation of Electronic Standards for the Transfer of Regulatory Information (ESTRI).
You can download the ICH Guidelines PDF using the link below.