ICH E5 Ethnic Factors Guidelines

E5 Ethnic Factors

E5(R1) Ethnic Factors in the Acceptability of Foreign Clinical Data

The ICH Harmonised Guideline was finalised under Step 4 in February 1998.

This document addresses the intrinsic characteristics of the drug recipient and extrinsic characteristics associated with environment and culture that could affect the results of clinical studies carried out in regions, and describes the concept of the "bridging study" that a new region may request to determine whether data from another region are applicable to its population.

Date of Step 4: 5 February 1998

Status: Step 5

Guidelines (Click the links below for complete guidelines)

E5(R1) Guidelines

E5 Q&As (R1) Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data

Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the E5 Guideline have resulted in the need for some clarification. This supplementary Questions and Answers document intends to clarify key issues.

Date of Step 4: 2 June 2006

Status: Step 5

Questions and Answers (Click the links below for complete guidelines)

E5 Q&As (R1) Questions & Answers

*These Guidelines Belongs to ICH website.