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Regulatory

ICH Guidelines

ICH Guidelines were created by The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

ICH aims to provide uniform standards for technical requirements for pharmaceuticals for human use. They are developed by regulatory and pharma industry authorities. The purpose of ICH guidelines is to ensure safe, effective and high-quality medicines are developed and registered efficiently.

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ICH Guideline Topics

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ICH Quality Guidelines

This area of quality includes topics like ICH guidelines related to stability studies.

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ICH Safety Guidelines

This comprehensive set of ICH guidelines help identify potential risks (e.g., carcinogenicity).

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ICH Efficacy Guidelines

Guidelines in this area relate to the design, conduct, safety and reporting of pharma clinical trials.

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Multidisciplinary Guidelines

These ICH guidances cover topics that don’t fit into the other topics. Examples include the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and others.

Learn more about ICH Guidelines

What are ICH Guidelines?

ICH guidelines are a set of guidances to ensure safe, effective and high-quality medicines are developed and registered efficiently. These guidelines have been adopted by regulatory authorities throughout the world.

Which ICH Quality Guidelines Relate to Stability?

ICH quality guidelines Q1A(R2) through Q1E cover stability, and the related titles are “Stability Testing of New Drug Substances and Products,” “Stability Testing: Photostability Testing of New Drug Substances and Products,” “Stability Testing for New Dosage Forms,” “Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products,” and “Evaluation of Stability Data.”

What is the ICH?

ICH stands for The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Founded in 1990, it brings together the regulatory and pharma industry authorities. Together they create the ICH guidelines.

ICH and CTD

The Common Technical Document (CTD) is maintained by ICH. In the CTD, quality, safety and efficacy information are put together in a common format. The CTD enabled the implementation of good review practices. It makes the regulatory review process simple. With the CTD, reformatting information for different ICH regulatory authorities is a thing of the past.CTD has five modules. The first is region specific and the remaining four are meant to apply to all regions.

FDA and ICH

The U.S. Food and Drug Administration (FDA) is a founding member of ICH. Per the agency's website, they promote ICH requirements and their use by by pharma regulatory authorities around the globe. As a member, FDA can, among other things, endorse draft ICH guidelines.

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