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.
- Clinical development of medicinal products for the treatment of cystic fibrosis - Scientific guideline
- Clinical investigation of medicinal products for the treatment of asthma - Scientific guideline
- Clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease (COPD) - Scientific guideline
- Clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Scientific guideline
- Post-marketing surveillance studies for metered dose inhalers with new propellant - Scientific guideline
- Replacement of chlorofluorocarbons (CFC) in metered dose inhalation products - Scientific guideline
- 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 -Scientific guideline