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

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

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

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

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/33407/2017Summary:

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 closedConsultation dates: 27/04/2016 to 31/10/2016Reference Number: EMA/CHMP/207892/2015Summary:

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 closedConsultation dates: 15/10/2014 to 15/01/2015Reference Number: EMA/CHMP/559636/2014Summary:

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

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