IPAC-RS Comments to EMA

IPAC-RS has submitted comments to EMA on the Concept paper on revision of the guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for the treatment of asthma in children and adolescents and Concept paper on the revision of the guideline on the pharmaceutical quality of inhalation and nasal products.

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