Sub menu

 

 

ICH E12 Principles for clinical evaluation of new antihypertensive drugs

We have adopted this International Scientific Guideline – ICH E12; CPMP/ICH/541/00 

Last updated

About this guideline

Adopted by the TGA: 28 February 2020

Overseas effective date: 1 June 2000

Categories: ICH | Efficacy

Clinical efficacy and safety | Cardiovascular system | Hypertension

TGA annotations:

This ICH document describes core principles for the evaluation of antihypertensive. It should be considered an 'ICH principle document' rather than an 'ICH guideline'. The reader should also refer to the most recent TGA adopted guidelines on the treatment of hypertension.

  • Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

Product types