Proposals for Global Harmonization of Regulations for Testing of Spacers and Valved Holding Chambers for Pressurized Metered Dose Inhalers

Abstract

Thought should be given to the desirability for similar approaches for the present transition to low global warming potential (LGWP) propellants for pressurized metered dose inhalers (pMDIs)  to be adopted by both European Medicines Agency (EMA) and the United States Food and Drug Administration  (FDA) for the performance testing of pMDIs that include the evaluation with an add-on spacer or valved holding chamber as part of the in vitro component for product registration. If such an add-on device was to be included as part of the registration package in either US or European regulatory environments, the content of United States Pharmacopeia (USP) chapter <1602> could support the process.