Clinical efficacy and safety: respiratory system
HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines
On Monday, 12 January 2026, between 07:00 and 10:00 CET (Amsterdam time), this website will be unavailable due to scheduled maintenance.
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