Clinical investigation of new medicinal products for the treatment of acute coronary syndrome - Scientific guideline

This guideline replaces 'Points to consider on the clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) without persistent ST segment elevation' (CPMP/EWP/570/98) and 'Points to consider on the clinical development of fibrinolytic medicinal products in the treatment of patients with ST segment elevation acute myocardial infarction (STEMI)' (CPMP/EWP/967/01).

Keywords: Acute coronary syndrome, STE-ACS, NSTE-ACS

Current effective version

Guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome - First version

Adopted Reference Number: EMA/CHMP/760125/2016 Legal effective date: 01/03/2018 Summary:

This guideline replaces 'Points to consider on the clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) without persistent ST segment elevation' (CPMP/EWP/570/98).

Document history - First version

Guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome - First version

Adopted Reference Number: EMA/CHMP/760125/2016 Legal effective date: 01/03/2018 Summary:

This guideline replaces 'Points to consider on the clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) without persistent ST segment elevation' (CPMP/EWP/570/98).

Overview of comments received on 'Guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome'

Reference Number: EMA/CHMP/33407/2017 Summary:

Overview of comments received on 'Guideline on clinical investigation of new medicinal products for the treatment

Draft guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome - First version

Draft: consultation closed Consultation dates: 27/04/2016 to 31/10/2016 Reference Number: EMA/CHMP/207892/2015 Summary:

Two CHMP guidelines have been previously developed to address clinical investigations of new medicinal products for the treatment of acute coronary syndrome (ACS).

Concept paper on the need for revision of the points to consider on the clinical investigation of new medicinal products for the treatment of acute coronary syndrome - First version

Draft: consultation closed Consultation dates: 15/10/2014 to 15/01/2015 Reference Number: EMA/CHMP/559636/2014 Summary:

An update of the Committe for Medicinal Products for Human Use points to consider on new medicinal products for the treatment of acute coronary syndrome is foreseen. This document covers a number of points that are proposed to be addressed in the update.

Document history - Superseded document

Points to consider on clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) without persistent st-segment elevation - Superseded document

Adopted Reference Number: CPMP/EWP/570/98 Legal effective date: 01/09/2000