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The International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) is an international association that seeks to advance the regulatory science of orally inhaled and nasal drug products (OINDPs) by collecting and analyzing data, and conducting joint research and…. 6 February 2024 Inhalation CROSS-INDUSTRY Organizations 2024 Drug Information Asso- ciation (DIA) China meeting's program, with expected partic- ipation from the China Center for Food and Drug International Exchange (CCFDIE), National Institutes for Food and Drug Con- trol (NIFDC), Chinese Pharma- copoeia (CHP), Centre for Drug Evaluation (CDE) and relevant colleagues from regulatory, indus- try and scientific institutions. Technical activities I PAC - R S p u b l i s h e d t h r e e high- impact papers in A A PS PharmSciTech: • An Overview and Discussion of N-nitrosamine Considerations for Orally Inhaled Drug Prod- ucts and Relevance to Other Dosage Forms, • Good Practices for the Labo- ratory Performance Testing of Aqueous Oral Inhaled Products (OIPs): An Assessment from the International Pharmaceutical Aerosol Consortium on Regu- lation and Science (IPAC-RS) and • Laboratory Performance Test- ing of Aqueous Nasal Inha- lation Products for Droplet/ Particle Size Distribution: An Assessment from the Interna- tional Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). e Materials Working Group prepared a paper on biocompat- ibility considerations for OIN- DPS, currently under review. lishing Bioequivalence. IPAC-RS met with the Center for Com- plex Generics (CRCG) to discuss mutual areas of interest. IPAC-RS also met with the FDA Office of Combination Products to discuss a way to mitigate divergent require- ments coming from the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) with respect to drug/ device combination products. IPAC-RS reviews United States Pharmacopeia (USP) updates reg- ularly and has provided comments on chapters including revised chapter <604> Leak Rate (of aerosol containers), <429> Light Diffraction Measurement of Par- ticle Size, and the following chap- ters published in Pharm.Forum 49(2): USP 87, 88, 1031, 660 and 661.2. Additionally, in May, joint IPAC-RS/IPAC/EFPIA (Euro- pean Federation of Pharmaceu- tical Industries and Associations) comments were developed on the document titled, "Questions and Answers on Data Require- ments When Replacing Hydro- fluorocarbons as Propellants in Oral Pressurized Metered Dose Inhalers" (European Medicines Agency Committee for Medicinal Products for Human Use (EMA/ CHMP) 83033/2023). IPAC-RS reviewed draft guidances from the Chinese and Japanese reg- ulatory authorities. e IPAC-RS Global Regulatory Review and Outreach China group secured an inclusion of IPAC-RS in the An overview e International Pharmaceutical Aerosol Consortium on Regula- tion & Science (IPAC-RS) is an international association that seeks to advance the regulatory science of orally inhaled and nasal drug products (OINDPs) by collecting and analyzing data, and conduct- ing joint research and develop- ment projects. 2023 was another productive and highly prolific year for IPAC-RS through the collabo- ration of 16 members and 10 asso- ciate members. Regulatory activities IPAC-RS remains highly active in the global regulatory space. One substantial effort was the devel- opment of joint comments by IPAC-RS and IPAC (the Inter- national Pharmaceutical Aerosol Consortium) to the European Chemicals Agency (ECHA) Reg- istration, Evaluation, Authorisa- tion and Restriction of Chemicals (REACH) regarding proposed per- and polyfluoroalkyl substances (PFAS) restrictions. IPAC-RS and IPAC also submitted comments to Health Canada on the Draft State of PFAS Report and Risk Manage- ment Scope for PFAS. Copies of the joint comments are available on the IPAC-RS website (https:// www.ipacrs.org/lgwppropellants). IPAC-RS Working Groups regu- larly engage with the United States Food and Drug Administration (FDA). IPAC-RS provided com- ments on the FDA draft guidance on Statistical Approaches to Estab- The International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS): An update and review of 2023 Mike Needham, BSc, MRSC, CChem; Jennifer Wylie, PhD and Mary Kate Bielinski, BS On behalf of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS)