Clinical efficacy and safety guidelines: respiratory system
HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines
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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