ICH Guidelines
ICH Guidelines
ICH Guidelines harmonize technical and regulatory requirements for drug development across the US, EU, and Japan. This collection brings together ICH quality, safety, efficacy, and multidisciplinary guidance documents in one place, a reference for teams navigating global development and registration standards.
The purpose of this guidance is to recommend international standards for, and promote harmonization of, the assessment of nonclinical developmental and reproductive toxicity (DART) testing necessary to support human clinical trials and marketing authorization for pharmaceuticals. The guidance describes potential strategies and study designs to supplement available data to identify,...
To properly inform decision-making by pharmaceutical companies, regulators, patients, physicians, and other stakeholders, clear descriptions of the benefits and risks of a treatment (medicine) for a given medical condition should be made available. Without such clarity, there is a concern that the reported treatment effect will be misunderstood. This addendum...
Two drug products containing the same drug substance or substances are considered bioequivalent if their bioavailabilities (rate and extent of drug absorption) after administration in the same molar dose lie within acceptable predefined limits. These limits are set to ensure comparable in vivo performance, i.e., similarity in terms of safety...
This Guideline is intended to provide internationally harmonised guidance on when it would be appropriate to use a selective approach to safety data collection in some late-stage pre-marketing or post- marketing studies, and how such an approach would be implemented. By collecting selective safety data, the burden to patients would...
This guideline is intended to provide recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples. Adherence to the principles presented in this guideline will improve the quality and consistency of the bioanalytical data in support of the...
This is the companion document for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidance for industry Q3C Impurities: Residual Solvents, which makes recommendations as to what amounts of residual solvents are considered safe in pharmaceuticals....
With the increasing globalization of drug development, it has become important that data from multiregional clinical trials (MRCTs) can be accepted by regulatory authorities across regions and countries as the primary source of evidence to support marketing approval of drugs (medicinal products). The purpose of this guidance is to describe...
The guideline for industry S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies (S3A guidance) has been successfully implemented since 1994, and in recent years, analytical method sensitivity has improved, allowing microsampling techniques to be used in toxicokinetic (TK) assessment. This question-and-answer (Q&A) document focuses on points to consider...
The ICH guidance Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and...
Pediatric drug development has evolved since the original guidance E11 Clinical Investigation of Medicinal Products in the Pediatric Population (ICH E11 (2000)) published, requiring consideration of regulatory and scientific advances relevant to pediatric populations. This addendum does not alter the scope of the original guidance. ICH E11 (2000), including this...
