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The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) and its working groups continued to advance a number of activities throughout 2018. IPAC-RS: An update on recent activities Robert Berger; Paul Atkins, PhD; Svetlana Lyapustina, PhD and Lee Nagao, PhD On behalf of IPAC-RS bioequivalence considerations for inhalation and nasal drug prod- ucts, extractables and leachables, biocompatibility and spray pat- tern. IPAC-RS also met with NIFDC representatives and the China National Pharmaceutical Packaging Association (CNPPA). e GRRO Europe Group has collaborated with the IPAC-RS Devices Working Group to moni- tor developments and contribute to cross-industry discussions relat- ed to the European Medical De- vice Regulation (MDR). For ex- ample, the IPAC-RS MDR Analysis Subgroup helped coordi- nate with the European Federation of Pharmaceutical Industries and Associations (EFPIA) European Biopharmaceutical Enterprises (EBE) on a letter to the European Commission (EC) outlining chal- lenges and areas needing further clarification in regards to the im- plementation of MDR Article 117. IPAC-RS joined EBE and a number of other stakeholder orga- nizations to co-sign the letter. IPAC-RS and other interested groups continue monitoring de- velopments by EC and will pro- vide support to EFPIA where needed. Members of the GRRO Europe Group also published a pa- per in AAPS PharmSciTech [Oc- tober 2018, Volume 19, Issue 7, pp. 3134-3140] on the European regulatory landscape for OINDPs. Finally, this Group continues to monitor the Brexit process with re- spect to EMA activities, and the status of impending guidelines (e.g., revisions to the quality and OIP bioequivalence and clinical e International Pharmaceutical Aerosol Consortium on Regula- tion and Science (IPAC-RS) and its working groups continued to advance a number of activities throughout 2018. In North America One of the Consortium's major ac- tivities in mid-year was the review and submission of comments on the United States Food and Drug Administration's (FDA) 2018 Draft Guidance for Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations. is work was or- ganized and driven by the consor- tium's Global Regulatory Review and Outreach North America Group (GRRO North America). e group collected and compiled comments from the various IPAC-RS technical working groups as well as the consortium's member companies. Specific working groups then liaised with the GRRO North America to review and re- fine the comments and submit them to the FDA Draft Guidance docket. Due to the number and extent of comments, the GRRO North America Group developed a second submission to the docket, requesting a public meeting or workshop to discuss the Draft Guidance with the FDA and other stakeholders. e GRRO North America Group is also monitoring and discussing output and research on complex generic drugs within the FDA Office of Generic Drugs (OGD) and is monitoring Health Canada activities. In Brazil, China and Europe e GRRO Brazil Group led the IPAC-RS collection and submis- sion of comments to the Brazilian regulatory agency's (ANVISA) Draft Resolution and Normative Instruction addressing equiva- lence considerations for inhalation and nasal drug products. e group then worked with ANVISA to organize a joint workshop at ANVISA in Brasilia in June to dis- cuss questions related to the Reso- lution and Normative Instruction. Topics included assessment and application of the population bio- equivalence (PBE) statistical ap- proach, the ANVISA regulatory framework for post-approval changes, and PK considerations. e group coordinated with the IPAC-RS PBE Working Group to follow up with ANVISA and will be sharing other scientific infor- mation and case studies. e GRRO China Group collabo- rated with the AAPS China Dis- cussion Group (AAPS CDG) and the China National Institutes for Food and Drug Control (NIFDC) to develop a workshop addressing drug delivery generally, as well as specific topics related to orally in- haled and nasal drug products (OINDPs). e workshop was held in September in Beijing and included industry, regulators and other stakeholders as speakers and attendees. IPAC-RS representa- tives from various consortium working groups and the board of directors gave presentations on a variety of timely topics, including the consortium's comments on the FDA MDI DPI Draft Guidance, 4 February 2019 Inhalation organizations Cross-industry

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