Issue Date: August 9, 2000
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Efficacy
Status: Draft
E12A Principles for Clinical Evaluation of New Antihypertensive Drugs
This document provides general principles for the clinical evaluation of new anti- hypertensive drugs. It describes core principles for the evaluation of antihypertensives that are accepted in the three ICH regions, but some region-specific differences remain. These differences may be harmonized in future, but it is important at present to refer to existing regional guidelines and to discuss the specific requirements with regional regulatory authorities, if required.
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