Questions and answers on data requirements when transitioning to low global warming potential (LGWP) propellants in oral pressurised metered dose inhalers - Scientific guideline

This document outlines expected multidisciplinary (including quality, non-clinical, clinical) aspects of oral pressurised metered dose inhalers (pMDIs) intended for delivery of the active substance into the lungs for the treatment of conditions affecting the lungs and airways (such as asthma and COPD). In particular, the document aims at providing advice regarding data requirements for the replacement of hydrofluorocarbons (HFCs) used as excipients (propellants) in oral pressurised metered dose inhalers with low global warning potential propellants (LGWP).

Keywords: question and answer, oral pressurised metered dose inhalers, hydrofluorocarbon replacement, propellants

Current version

Questions and answers on data requirements when transitioning to low global warming potential (LGWP) propellants in oral pressurised metered dose inhalers

AdoptedConsultation dates: 05/04/2023 to 31/05/2023Reference Number: EMA/477469/2023 Corr. 1

Overview of comments received on 'Questions and answers on data requirements when transitioning to low global warming potential (LGWP) propellants in oral pressurised metered dose inhalers' (EMA/CHMP/83033/2023)

Reference Number: EMA/251450/2023