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In the past 12 months, IPAC-RS has been actively working on the goals set forth in its strategic plan. It is also planning for the 2020 joint IPAC-RS/RDD Symposium in Palm Desert, California in late April. Inhalation February 2020 5 IPAC-RS: An update on recent activities Paul Atkins, PhD; Carla Vozone, Pharm.D, MBA; Stacey Wierzba, MA and Svetlana Lyapustina, PhD on behalf of IPAC-RS products. e group also hopes to develop a China-based work- shop for 2020, focusing on regu- latory topics related to review and approval of OINDPs in China. e GRRO-Europe has been actively engaging with European regulators. In addition to com- menting on the European Med- icines Agency (EMA) "Guide- line on the Quality Requirements for Drug-Device Combinations," IPAC-RS submitted a joint let- ter to the European Commission with the IPAC-RS Devices Work- ing Group Medical Device Regu- lations (MDR) subteam on "Rule 20 of Annex VIII of MDR" and provided feedback on the Med- icines and Healthcare Products Regulatory Agency (MHRA)'s "Consultation on the Application of Analytical Quality by Design concepts to pharmacopeial stan- dards for medicines." e GRRO-Brazil working group met with the Brazilian Health Regulatory Agency (ANVISA) in August to discuss the newly-is- sued Resolution (RDC 278) and Normative Instruction (IN 33) on OINDP therapeutic equiva- lence, and co-authored and pub- lished an "Overview of Brazil- ian Requirements for erapeutic Equivalence of Orally Inhaled and Nasal Drug Products" in the June issue of AAPS PharmSciTech. e group also held three discussions with ANVISA regarding recent OINDP regulations and plans for the upcoming IPAC-RS/ANVISA Population Bioequivalence (PBE) webinar, currently scheduled for early 2020. Since its formation in 2001, the In- ternational Pharmaceutical Aerosol Consortium on Regulation & Sci- ence (IPAC-RS) has been serving the orally inhaled and nasal drug products (OINDPs) community by driving scientific and regulatory advancements in the field. What's new e year 2019 has been very busy for IPAC-RS. In the past 12 months, IPAC-RS has been actively working on the goals set forth in its strategic plan. e Consortium engaged with regula- tory and standard-setting author- ities, provided up-to-date infor- mation to the members on rele- vant developments, identified and publicized the OINDP industry's positions on key issues of regula- tory science, provided a forum for member discussions, and actively participated in conversations in the wider stakeholder community. In North America e Consortium and its Global Regulatory Review and Outreach (GRRO)-North America work- ing group continued to focus on engagement with the United States Food and Drug Administra- tion (FDA), including follow-up related to the 2018 Draft Guid- ance for Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) products-quality consider- ations. IPAC-RS also submitted comments to the FDA on draft guidances titled "Contents of a Complete Submission for resh- old Analyses and Human Factors Submissions to Drug and Bio- logic Applications Guidance for Industry and FDA Staff," "Prin- ciples of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff," and "Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format." In addition to the FDA, IPAC-RS continued its commitment to work- ing closely with the US Pharma- copeia (USP), providing feedback on revised chapters <601>, <1603> and <1604>, as well as responding to FDA comments on the stimuli article, "e Application of Abbre- viated Impactor Measurement and Efficient Data Analysis in the Life- cycle of an Orally-Inhaled Prod- uct: A Roadmap." In China, Brazil and Europe e GRRO-China working group led the IPAC-RS collection and submission of comments to Chi- na's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) "Oral Inhalation Formulations of Generic Pharmaceuticals and Human Bio- equivalence; Guiding Principles for Research." e group submitted comments on the inhalation and nasal-related chapters 0111 (Inha- lation Preparations), 0112 (Sprays) and 0113 (Aerosols) developed by the Chinese Pharmacopeia, and also commented on the China Pharmaceutical Packaging Associ- ation (CNPPA) draft guideline on extractables studies for inhalation organizations Cross-industry