Several ICH guidelines that address aspects of design, conduct, analysis and reporting of clinical trials will help implement the concepts of the Complete Clinical Data Package.

Dec 11, 2024 · This International Conference on Harmonization (ICH) guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data...

This document recommends a framework for evaluating the impact of ethnic factors upon a medicine's effect, i.e., its efficacy and safety at a particular dosage and dose regimen. Read together with ICH E5 (R1) Ethnic factors in the acceptability of foreign clinical data - …

The purpose of this guidance is to facilitate the registration of medicines among ICH regions* (see Glossary) by recommending a framework for evaluating the impact of ethnic factors* upon a medicine’s effect, i.e., its efficacy and safety at a particular dosage* and dose regimen*.

This Guideline complements the guidance on MRCTs provided in ICH E5 (R1) Guideline and facilitates MRCT data acceptance by multiple regulatory agencies. An extensive set of training materials including 7 modules has been developed to promote the efficient and consistent implementation of the E17 Guideline in the context of an evolving drug ...

Home Regulatory Information Search for FDA Guidance Documents E5 Ethnic Factors in the Acceptability of Foreign Clinical Data

The ICH-E5 guideline provides a general framework for evaluating the potential impact of ethnic factors on the acceptability of foreign clinical data, with the underlying objective of minimizing duplication of clinical data, and it also describes the requirement of bridging studies for extrapolation of foreign clinical data to a new region.

E5 addresses primarily how development programs in one or two regions might support approval in another region.

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ICH E5 is intended to facilitate the registration of drugs and biologics among ICH regions by recommending a framework for evaluating the impact of ethnic factors on a drug’s effect, i.e., its ...