Clinical efficacy and safety: respiratory system

The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used in conditions affecting the lungs and airways help medicine developers prepare marketing-authorisation applications.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

Guidelines

• Clinical investigation of medicinal products for the treatment of idiopathic pulmonary fibrosis (IPF)
• Clinical development of medicinal products for the treatment of cystic fibrosis
• Clinical investigation of medicinal products for the treatment of asthma
• Clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease (COPD)
• Clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome
• Post-marketing surveillance studies for metered dose inhalers with new propellant
• Replacement of chlorofluorocarbons (CFC) in metered dose inhalation products
• Requirements for clinical documentation for orally inhaled products including requirements for demonstration of therapeutic equivalence between 2 inhaled products for use in treatment of asthma & chronic obstructive pulmonary disease
• Allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations