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.

Hypertension

Guidelines

• Clinical investigation on medicinal products in the treatment of hypertension
• ICH E12 Principles for clinical evaluation of new antihypertensive drugs
• Paediatric addendum to the guideline on clinical investigation on medicinal products in the treatment of hypertension - Scientific guideline

Lipid disorders

Guidelines

• Clinical investigation of medicinal products in the treatment of lipid disorders
• Paediatric addendum to the guideline on clinical investigation of medicinal products in the treatment of lipid disorders - Scientific guideline

Pulmonary arterial hypertension

Guidelines

• Clinical investigation of medicinal products for the treatment of pulmonary arterial hypertension
• Paediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of pulmonary arterial hypertension - Scientific guideline

Arrythmias

Guidelines

• 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 - Scientific guideline
• ICH E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs - Scientific guideline
• ICH E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs - Scientific guideline

Venous thromboembolism

Guidelines

• Need for a paediatric addendum of the guideline on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease - Scientific guideline
• Clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in non-surgical patients - Scientific guideline
• Clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery - Scientific guideline
• Clinical investigation of medicinal products for the treatment of venous thromboembolic disease

Concept papers

• Need for a paediatric addendum of the guideline on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease - Scientific guideline

Heart failure

Guidelines

• 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 - Scientific guideline
• Clinical investigation of medicinal products in the treatment of chronic heart failure

Coronary artery disease

Guidelines

• Clinical and non-clinical evaluation during the consultation procedure on medicinal substances contained in drug-eluting (medicinal-substance-eluting) coronary stents - Scientific guideline
• 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) - Scientific guideline
• Clinical investigation of new medicinal products for the treatment of acute coronary syndrome

Other

Guidelines

• Clinical investigation of medicinal products in the treatment of peripheral-arterial occlusive disease - Scientific guideline
• Evaluation of medicinal products for cardiovascular disease prevention

Reflection papers

• Assessment of cardiovascular safety profile of medicinal products
• Assessment of cardiovascular safety profile of medicinal products
• Gender differences in cardiovascular diseases

Position statements

• Regulatory requirements for the authorisation of low-dose modified-release acetyl-salicylic-acid formulations in the secondary prevention of cardiovascular events

Concept papers

• Need for a reflection paper on assessment of cardiovascular safety of oncology medicinal products