ICH Guidelines (E/Q/M Series)

ICH guideline on definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, and related terms.

ICH guideline on qualification of genomic biomarkers for use in drug development.

ICH guideline on general principles for planning and design of multi-regional clinical trials (MRCTs).

ICH guideline on genomic sampling and management in clinical studies.

ICH guideline on optimization of safety data collection in late-stage pre-approval or post-approval clinical trials.

ICH guideline on adaptive design clinical trials (where applicable), describing planning, control of bias, and interpretability considerations.

ICH guideline describing clinical safety data management for expedited reporting, including key concepts for reporting serious unexpected adverse reactions.

ICH guideline and data standard for Individual Case Safety Reports (ICSRs) used in pharmacovigilance reporting, revision R3.

ICH guideline on periodic benefit-risk evaluation reporting, supporting periodic safety update reporting across regions.

ICH guideline on post-approval safety data management, including definitions and standards relevant to post-marketing safety reporting.

ICH guideline on pharmacovigilance planning, describing principles for safety specification and planned PV activities.

ICH guideline describing the Development Safety Update Report (DSUR) to provide annual safety updates during clinical development.

ICH guideline describing the structure and content of a Clinical Study Report (CSR) for clinical trials.

ICH guideline on dose-response information to support clinical development and labeling decisions.

ICH guideline on ethnic factors in the acceptability of foreign clinical data, supporting bridging strategies and extrapolation across regions.

ICH Good Clinical Practice guideline revision R2, introducing stronger focus on risk-based quality management and oversight of vendors/CROs.

ICH guideline for Good Clinical Practice (GCP), revision R3, focusing on quality by design, risk-based approaches, and modern trial conduct expectations.

ICH guideline addressing studies in support of special populations, including geriatric considerations.

ICH guideline on General Considerations for Clinical Studies, emphasizing quality by design across clinical development.

ICH guideline covering statistical principles for clinical trials, including key concepts like estimands, analysis sets, and multiplicity.

ICH addendum introducing the estimands framework for defining treatment effects aligned with trial objectives and handling of intercurrent events.

ICH guideline covering MedDRA (Medical Dictionary for Regulatory Activities) and its use as a controlled terminology for coding adverse events and medical concepts.

ICH guideline on bioanalytical method validation, describing expectations for accuracy, precision, selectivity, stability, and documentation.

ICH guideline covering electronic standards for regulatory submissions (e.g., eCTD specifications and related standards).

ICH guideline on nonclinical safety studies to support human clinical trials and marketing authorization for pharmaceuticals.

ICH guideline describing the CTD structure and organization for quality, nonclinical, and clinical modules.

ICH guideline on assessment and control of DNA reactive (mutagenic) impurities to limit potential carcinogenic risk.

ICH guideline related to the electronic Common Technical Document (eCTD) and its specifications in supported regions.

ICH guideline on Biopharmaceutics Classification System (BCS)-based biowaivers, describing when in vivo BE studies may be waived.

ICH guideline describing a Pharmaceutical Quality System (PQS) model for effective quality management across development, manufacturing, and product discontinuation.

ICH guideline on development and manufacture of drug substances (chemical entities and biotechnological/biological entities).

ICH guideline on Pharmaceutical Product Lifecycle Management, enabling predictable post-approval change management and regulatory flexibility.

ICH guideline on continuous manufacturing of drug substances and drug products.

ICH guideline on Analytical Procedure Development, supporting robust method development and lifecycle management.

ICH guideline describing stability testing requirements for new drug substances and products, revision R2.

ICH guideline on photostability testing of new drug substances and products.

ICH guideline on stability testing for new dosage forms.

ICH guideline on bracketing and matrixing designs for stability testing of drug substances and products.

ICH guideline on evaluation of stability data and establishing shelf life/retest periods.

ICH guideline on stability data package for registration in climatic zones III and IV (historically referenced; status varies and may be withdrawn).

ICH guideline on validation of analytical procedures, revision R2, focusing on method performance characteristics and validation expectations.

ICH guideline on impurities in new drug substances, including reporting, identification, and qualification thresholds.

ICH guideline on impurities in new drug products, including thresholds for reporting, identification, and qualification.

ICH guideline on residual solvents, including permitted daily exposures and classification of solvents.

ICH guideline on elemental impurities, providing risk-based limits and assessment approaches for elemental contaminants in drug products.

ICH guideline on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions (harmonisation of selected general chapters).

ICH guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, revision R2.

ICH guideline on quality of biotechnological products: analysis of the expression construct in cells used for production.

ICH guideline on stability testing of biotechnological/biological products.

ICH guideline on derivation and characterization of cell substrates used for production of biotechnological/biological products.

ICH guideline on comparability of biotechnological/biological products subject to manufacturing process changes.

ICH guideline on specifications for new drug substances and products (chemical substances).

ICH guideline on specifications for biotechnological/biological products.

ICH guideline on Good Manufacturing Practice for active pharmaceutical ingredients (APIs).

ICH guideline on Pharmaceutical Development, including quality by design concepts, design space, and enhanced product/process understanding.

ICH guideline on Quality Risk Management, revision R1, describing principles and tools to manage risk to quality across the product lifecycle.