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The International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) is a global non-profit association comprised of companies that develop, manufacture and market inhaled and nasal drugs and biologics (INDBs). Its mission is to advance the science—particularly regulatory science—of INDBs through data analysis, collaborative research and engagement with the wider community. 6 February 2026 Inhalation CROSS-INDUSTRY Organizations 2025 highlights of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) Mary Kate Bielinski IPAC-RS Secretariat Introduction e International Pharmaceuti- cal Aerosol Consortium on Reg- ulation & Science (IPAC-RS) is a global non-profit association com- prised of companies that develop, manufacture and market inhaled and nasal drugs and biologics (INDBs). Its mission is to advance the science—particularly regula- tory science—of INDBs through data analysis, collaborative research and engagement with the wider community. is article highlights IPAC-RS's key initiatives in 2025. Subteam and Working Group activities In the area of inhaled and nasal bio- logics, several subteams are actively collaborating to establish current best practices and develop case studies. e Analytical Subteam is evaluating approaches for test- ing biological formulations; and the Formulation-Manufacturing- Device Subteams are putting together case studies for develop- ment of a liquid and a dry powder formulation. e Novel Modali- ties Subteam is focusing on muco- sal immunization approaches, and the Regulatory Subteam is analyzing regulatory guidance for inhaled and nasal biologics and identifying gaps. e Nasal Working Group contin- ues to discuss advanced methods for nasal product testing, regula- tory and pharmacopeial standards and reliability expectations for emergency-use nasal products. e Nasal Pediatrics Subteam has pub- lished its compilation of informa- tion on excipients. e Nasal Casts Subteam was recently established to address challenges and gaps related to the use of nasal casts for develop- ment, testing and regulatory review of nasal products. e Aerodynamic Particle Size Dis- tribution (APSD) Working Group progressed development of an APSD database and started a collabora- tive high- payload Next Generation Impactor (NGI) DPI experiment. e Dissolution Subteam is planning round-robin testing to advance data-based discussions of dissolution method standardiza- tion and validation. Global Regulatory Review and Outreach (GRRO) e GRRO China Working Group remained very active in 2025. ey discussed Chinese Pharmacopeia (ChP) chapter 9017 (Guideline for Evaluation of Spray Characteris- tics of Inhalation and Nasal Prepa- rations) and ChP chapter 0111 (Guidelines for Inhalation Prepara- tions). e team reviewed the drug registration testing process and overarching legislation in China. ey also spearheaded IPAC-RS participation at the International Conference of the Inhalation Drug Delivery Association (IDDA) held in Nanjing, China. IPAC-RS speakers gave an overview of the consortium's portfolio as well as the presentation, "Key Considerations When Reformulating Pressurized Metered Dose Inhalers with Low Global Warming Potential Propel- lants (LGWPP)." Clarifying regulatory approaches related to pressurized metered dose inhalers (pMDIs) using lower global warming potential propel- lants has been a critical priority globally. IPAC-RS collaborated with the International Society for Aerosols in Medicine (ISAM) to prepare and conduct a stake- holder workshop. ose presenta- tions are available at https://www. ipacrs.org/new-mdis. e GRRO IPAC-RS Alternative Propellants Working Group published an analysis of regulatory gaps and a proposal for possible pathways to regulatory approval for use glob- ally, as described in the IPAC-RS publication, "Enable Transition to New Propellants 2025.pdf." Forums and roundtables Scientific innovations and regu- latory approaches for nasal prod- ucts were discussed during a Nasal Innovation Forum (NIF) held in September. More than 140 indi- viduals from over 50 life-sciences companies and other industry, academia and regulatory organi- zations came together to discuss small-molecule and biologics nasal delivery. Recordings are available at IPAC-RS Nasal Inno- vation Forum. Based on the success of NIF-2025, IPAC-RS is planning a follow-up event to be held September 16-17, 2026. Please save the dates and watch News and Events | IPAC-RS for more information!