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16 June 2024 Inhalation that for injectable forms. However, nasal vaccines may require additional toxicological data due to the unique risks associated with local administration in the nasal cavity, and any new excipients or adjuvants used may need additional toxicological assessment for regulatory approval [5]. Clinical trials for nasal vaccines must address the broader immune responses they produce, including T-cell activation, and any associated nasal delivery devices will be subject to standard regulatory evaluations for combination drug-device products [5]. Emerging markets such as the BRIC nations (Brazil, Russia, India and China) are increasingly adopting nasal spray medications and their regulatory agencies are considering adopt- ing FDA-like control strategies. Advancements in technology are influencing the development of nasal medication delivery systems and medical devices, bringing new challenges in software integration, data protection and complex device components. e reg- ulatory landscape is rapidly evolving to accommodate these technological advancements and ensure patient safety and efficacy. Conclusions Nasal powder formulations represent a significant stride in drug delivery innovation and take advantage of the nasal passages as a convenient, needle-free route for systemic and CNS drug delivery. e potential for simplified preservative-free compositions, increased chemical stability and enhanced capacity for higher drug loads are additional benefits offered by formu- lating as a dry powder. Leveraging these advantages, the applications of nasal powders extend to the treat- ment of a variety of non- respiratory indications such as neurological disorders, vaccine delivery and emer- gency anaphylaxis treatment. Application of established production technologies, such as spray drying, allows for the design and man- ufacture of readily dispersible, shelf-stable powders in a scalable process. Further, spray drying can be utilized to improve bioavailability through solubil- ity enhancement and incorporation of mucoadhesive excipients. Newer technologies such as TFFD also have demonstrated utility for nasal powder produc- tion, particularly for biopharmaceuticals sensitive to manufacturing stressors. Despite a limited number of nasal powder products on the market, successful approval of Onzetra Xsail and Baqsimi have helped to set approval standards and can serve as regulatory precedents, reducing risk for future development efforts in this formulation space. With drug developers and approvers evolving to address the unique considerations of nasal drug delivery, the future holds promise for nasal powders as a robust and adaptable platform in the pharmaceu- tical landscape. To overcome market entry challenges, manufac- turers need to optimize powder manufacturing, have a thorough understanding of the interaction between the powder and delivery devices, and con- duct a comprehensive evaluation of the local effects of powder insufflation in the nasal environment [1]. In addition, advancements that improve the effectiveness and safety of nasal drug delivery are expected to drive growth in the market for nasal drug delivery systems [30]. Commercial examples: Baqsimi ® and Onzetra ® Xsail ® In 2016, Onzetra Xsail (OptiNose US, Inc.) became the first nasal powder for systemic therapy to be approved for the acute treatment of migraine in adults [29]. is product is considered unique due to its breath-powered device and neat API formulation. e active ingredient in Onzetra Xsail is sumatriptan succinate, classified as a small molecule. Sumatriptan has been demonstrated effective in relieving migraine symptoms. It works by narrowing blood vessels in the brain, stopping pain signals from being sent to the brain and blocking the release of substances that cause nausea, light sensitivity and other migraine symptoms. is can make it a highly targeted and effective treatment for migraine episodes. Baqsimi, a nasal powder formulation of glucagon, developed by Eli Lilly and now marketed by Ampha- star Pharmaceuticals, is used for the treatment of severe hypoglycemia in individuals with diabetes. Approved in 2019, it was the first FDA-approved emergency treatment for hypoglycemia that could be delivered without a needle [31]. Glucagon is a hor- mone that raises blood sugar levels, and Baqsimi is designed to be a user-friendly, needle-free option for quickly increasing blood sugar in emergency situa- tions. Baqsimi powder is produced by freeze drying and filled into the Aptar UDSp. e nasal pow- der form of glucagon can offer several advantages, including ease of administration, especially in situ- ations where intravenous access is challenging or in cases where patients or caregivers are not comfortable with injection-based treatments. is makes Baq- simi a valuable addition to the emergency treatment options for severe hypoglycaemia. Global regulatory trends Global regulatory bodies, such as the United States Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada, are leading the way in harmonizing standards, with the International Council for Harmonisation of Tech- nical Requirements for Pharmaceuticals for Human Use (ICH) playing a significant role. While there are no universal regulations for orally inhaled or nasal medication products, the regulatory framework in these countries is well-established [32]. In the US, the regulatory process for nasal vaccines is similar to