Regulatory eCTD

ICH Guidelines

What is the ICH and what are ICH Guidelines?

ICH’s Mission

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was created in 1990 and brings together regulatory and pharmaceutical industry authorities to discuss scientific and technical aspects of drug registration and development.

ICH’s objective is to bring about greater standardization worldwide to ensure that safe, effective and high-quality medicines are developed and registered in the most resource-efficient manner. Greater uniformity can be achieved through the creation of ICH Guidelines through a process of scientific consensus with regulatory and pharma industry experts working side-by-side.

Free Resources

Select all the resources you’re interested in downloading

ICH Guideline Topics

Quality guidelines: These guidelines help ensure that harmonization achievements from a quality perspective conform with such measuring sticks as conduct of stability studies, defining relevant thresholds for impurities testing, and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

Safety guidelines: A comprehensive set of ICH guidelines that help identify potential risks, such as carcinogenicity, genotoxicity and reprotoxicity. An example is a non-clinical testing strategy for evaluating the QT interval prolongation liability, the single most important cause of drug withdrawals in recent years.

Efficacy guidelines: These guidelines relate to the design, conduct, safety and reporting of pharmaceutical clinical trials. They also include novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to create better targeted drugs.

Multidisciplinary guidelines: This covers pharma topics that don’t neatly fit into either the Quality, Safety or Efficacy guidelines, and includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD), and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

ICH CTD Guidelines

The ICH’s agreement to assemble quality, safety and efficacy information in a common format is dubbed the Common Technical Document (CTD). That practice has revolutionized regulatory review processes and led to a harmonized electronic submission that has allowed the implementation of good review practices. For pharmaceuticals, the CTD has eliminated the need to reformat information for the submission to different ICH authorities. In ICH CTD guidelines, the CTD is organized into five modules.

Module 1 (Regional Administrative Information) is region specific and Modules 2¬–5 are meant to be common for all regions. Module 2 is a Quality Overall Summary; Module 3 is Quality; Module 4 is Nonclinical Study Reports; and Module 5 is Clinical Study Reports. In 2003, the CTD became the mandatory format for new drug applications in the European Union (EU) and Japan, and the highly encouraged format of the U.S. Food and Drug Administration (FDA).

ICH Guidelines for Pharmaceuticals

ICH Guidelines incorporate a variety of quality guidances to evaluate pharmaceutical products that include stability analysis, an evaluation of impurities and quality risk management:

  • Q1A (R2) — Stability Testing of New Drug Substances and Products. This guidance is for analyzing the product to determine its stability in a variety of environmental conditions.

  • Q1B — Stability Testing: Photostability Testing of New Drug Substances and Products. Also, for stability testing, this guideline studies the effect of light on pharma products.

  • Q1C — Stability Testing for New Dosage Forms. This is an annex to the ICH Harmonised Tripartite Guideline on Stability Testing for New Drugs and Products.

  • Q1D — Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products. This applies to stability testing of a product using bracketing and matrixing.

  • Q1E — Evaluation for Stability Data. This section addresses the method of evaluation of data after the analysis of drug products for stability testing.

Attain Pharmaceutical Harmony With ICH Guidelines Through MasterControl’s Regulatory Excellence

MasterControl’s Regulatory Excellence solutions are aimed at helping pharmaceutical companies ensure that their products are ICH-compliant. Regulatory Excellence solutions automate and accelerate regulatory information management (RIM) throughout the product life cycle from a single centralized system. Learn more about how MasterControl Regulatory Excellence can help you achieve harmony with ICH Guidelines here.

MasterControl and the FDA

MasterControl and its partner, i4DM, have served as the quality management system (QMS) providers for the FDA’s Office of Regulatory Affairs since 2009. They also serve as QMS providers for the Division of Pharmaceutical Analysis, part of the FDA’s Center for Drug Evaluation and Research (CDER).