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.
This Addendum applies to all pharmaceuticals that need carcinogenicity testing as described in ICH S1A. For biotechnology-derived pharmaceuticals, refer to the ICH guidance for industry S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (May 2012))....
International Council for Harmonisation; Draft Guidance for Industry...
This question-and-answer (Q&A) document is intended to clarify key issues to facilitate implementing the ICH guidances for industry E14 Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (October 2005) and S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human...
This document is an appendix to the Implementation Guide (IG) for the ‘International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Electronic Transmission of Individual Case Safety Reports (ICSRs)’....
The E2B(R3) document package comprises four materials. The main document is the ICSR Implementation Guidance, which includes E2B(R3) data elements and message specifications; the BFC document is an appendix to the guide provided separately. The ICH ICSR XML schema set includes all necessity schema files for creating ICH ICSR messages...
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed, registered, and maintained in the most resource-efficient manner. By harmonizing the regulatory expectations in regions around the...
This guidance provides recommendations for permitted daily exposures (PDEs) for three additional residual solvents: (1) 2-methyltetrahydrofuran, (2) cyclopentyl methyl ether, and (3) tert-butyl alcohol. This guidance is intended to recommend acceptable amounts for these residual solvents in pharmaceuticals for the safety of the patient. As part of the maintenance process...
The purpose of this document is to recommend international standards for, and promote harmonisation of, the nonclinical safety assessments to support the development of pharmaceuticals intended for pediatric use. Harmonisation of the guidance for nonclinical safety studies will define the current recommendations and reduce the likelihood that substantial differences will...
The examples provided in sections I.A through I.F of the ICH Q12 Annexes are mock examples provided for illustrative purposes. They only suggest how the tools described in sections III, IV, and V of the ICH Q12 guidance could be applied, and should not be used as a template or...
This guidance provides a framework to facilitate the management of postapproval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner. A harmonized approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the...
