Clinical efficacy and safety: cardiovascular system
The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used in conditions affecting the cardiovascular system help medicine developers prepare marketing authorisation applications.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
- Addendum to the note for guidance on antiarrhythmics on atrial fibrillation and atrial flutter
- Antiarrhythmics
- Clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation
- ICH E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
- ICH E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
- Need for a paediatric addendum of the guideline on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease
- Clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in non-surgical patients
- Clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery
- Clinical investigation of medicinal products for the treatment of venous thromboembolic disease
- Clinical investigation of medicinal products for the treatment of acute heart failure
- Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure
- Clinical investigation of medicinal products in the treatment of chronic heart failure
- Clinical and non-clinical evaluation during the consultation procedure on medicinal substances contained in drug-eluting (medicinal-substance-eluting) coronary stents
- Clinical investigation of anti-anginal medicinal products in stable angina pectoris
- Clinical development of fibrinolytic medicinal products in the treatment of patients with ST -segment elevation acute myocardial infarction (STEMI)
- Clinical investigation of new medicinal products for the treatment of acute coronary syndrome
- Clinical investigation of medicinal products in the treatment of peripheral-arterial occlusive disease
- Evaluation of medicinal products for cardiovascular disease prevention
- Assessment of cardiovascular safety profile of medicinal products
- Assessment of cardiovascular safety profile of medicinal products
- Gender differences in cardiovascular diseases
Position statements