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Updated: Feb 6, 2026

Modeling and Simulations of Olfactory Drug Delivery with Passive and Active Controls of Nasally Inhaled Pharmaceutical Aerosols
Published on: May 20, 2016
European Regulatory Developments for Orally Inhaled and Nasal Drug Products
Carlos Santos1, Gustavo Marco2, Lee M Nagao3
1Merck & Co., Inc., Kenilworth, New Jersey, USA.
Abstract:
Orally inhaled and nasal drug products (OINDP) are regulated in Europe via national (country) legislation and guidelines and/or legislation established in the European Union and resulting guidelines developed by the European Medicines Agency (EMA). Recent movement in EMA guidance and European Commission legislation implies potential significant changes in OINDP regulation. The UK exiting the European Union ("Brexit") has also raised a number of questions related to OINDP development and regulation in the region. The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) European outreach working group provides and overview and analysis of the current state of European regulatory activity for OINDP (International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) 2018).
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