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This article provides a brief history of the formation of The European Pharmaceutical Aerosol Group (EPAG), including its constitution, objectives, structure, influence, publications and input to regulatory guidance documents. A list of the organization’s publications and references since 2000 is also included. 20 August 2023 Inhalation An overview of The European Pharmaceutical Aerosol Group (EPAG) A brief history of the formation of EPAG, its constitution, objectives, structure, influence, publications and input to regulatory guidance documents Tarlochan S. Purewal, Jolyon P. Mitchell, PhD and Hlack Mohammed, PhD On behalf of the European Pharmaceutical Aerosol Group (EPAG) Background and formation Prior to the transition from chlorofluorocarbon (CFC) to hydrofluoroalkane (HFA) propellants for the metered dose inhalers (MDIs), there was little collaboration among companies developing pharma- ceutical products for administration to the human respiratory tract. However, by the 1990s, a real- ization was emerging among those involved in the development and manufacture of orally inhaled and nasal drug products (OINDPs) that significant scien- tific and technical benefits could accrue if a more col- laborative approach was adopted across the industry to address the common problems. Such an outcome was already evident as the result of the following (not exhaustive) list of collaborative activities taking place during the late 1990s: • To address the transition from CFC to HFA propellants, an industry-wide consortium, the International Pharmaceutical Aerosol Consor- tium (IPAC), collaborated on the development of a toxicological data package to assist in gaining regulatory approval of products formulated with the new propellants. • e Inhalanda working party of the European Pharmacopeia (PhEur) coordinated a collabora- tive study on aerodynamic particle size methods. • IPAC continued to collaborate and address new regulatory guidance documents concerning inhal- ers coming from both European and US regu- latory agencies, eventually becoming IPAC-RS (International Pharmaceutical Aerosol Consor- tium on Regulation and Science) in 2001. • A European-driven industrial consortium was established in 1998 to develop a cascade impactor designed specifically for testing inhaled products for the pharmaceutical industry, eventually over- seeing the design, archival calibration and produc- tion of the first Next Generation (pharmaceutical) Impactors (NGIs). During 1999, scientists representing various phar- maceutical companies involved at the time with OINDPs began collaborating and formed a Euro- pean group focused on chemistry, manufacturing and control (CMC) aspects. e inaugural meet- ing of these experts from ten organizations, includ- ing representatives of Glaxo-Wellcome (now GSK), Boehringer Ingelheim, Astra, Rhone Poulenc Rorer (later Aventis Pharma, Sanofi-Aventis and then Aven- tis), Novartis and Innovata Biomed (now Vectura), was held at Loughborough, United Kingdom in December 1999. e name "European Pharmaceu- tical Aerosol Group (EPAG)" was agreed upon as the title to identify the new collaboration. By 2002, EPAG had expanded to 16 companies. Constitution A constitution was developed during the first year of operation that formally set out the detailed struc- ture and organization, objectives, membership crite- ria and policies regarding published commentaries, reports, conference papers and archival journal arti- cles. e constitution has undergone revision sev- eral times during the 22 years of the life of EPAG to reflect the evolving nature of the industry as well as the way the collaboration functions. Key highlights include the following: • EPAG is set up as a voluntary, non-profit consortium.

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