Multidisciplinary: orally inhaled products

The European Medicines Agency's scientific guidelines on orally inhaled products help medicine developers prepare marketing authorisation applications for human medicines.

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

Guidelines

• 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

Questions and answers

• Questions and answers on data requirements when replacing hydrofluorocarbons as propellants in oral pressurised metered dose inhalers - Scientific guideline