The challenging process of taking an inhaled product to market, via development and manufacturing, in the EU and USA led Martin Oliver, SVP Delivery Management – DPI and pMDI Platforms, to share his expertise in an in-depth analysis in PMPS May: Inhalation Technology Supplement 2021. Titled “How the EU and US are aligning guidance for inhalation products”, Martin gives his insights and views on how the FDA and EMA are joining their thinking to reduce costs and save time.
Canada and Brazil have taken a very similar approach to the EU, with added elements in the way that the FDA looks at data. China recently issued guidelines that are broadly similar to the EU approach, but which take in aspects of the US guidelines as well. Globally, the view of inhaled products is starting to align around key pieces of information.
The new in vitro methods and approaches to product characterisation that are now appearing may reduce the time and cost to demonstrate bioequivalence. This gives developers and innovators the opportunity to characterise products in a way that was previously unattainable, with the aim of reducing both time and cost of drug development.
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This article is taken from PMPS May: Inhalation Technology Supplement 2021, pages 16-18. © Samedan Ltd