Regulatory Aspects of Nasal and Pulmonary Spray Drug Products

Abstract

This chapter highlights all of the tests currently required by the Food and Drug Administration (FDA) and European Medicines Agency (EMEA)/Health Canada for marketing and sale of orally inhaled and nasal drug products (OINDPs) in the USA, Europe, and Canada respectively. The list of tests is quite long and complex, so a thorough understanding of them, including how and when to conduct the tests, is crucial to acceptance by these regulatory agencies. Using a risk based approach based on product understanding and targeted indication/patient group is highly recommended to streamline the development process, produce high-quality test data, and, ultimately, to help patients. This chapter also shows that numerous discrepancies exist between the FDA and EMEA/Health Canada guidelines with regard to OINDP development and testing. These discrepancies can have a significant impact on how the product is developed, tested, documented, and presented to the appropriate regulatory agency for approval. Lastly, the FDA, EMEA, Health Canada, and industry groups such as IPAC–RS, PQRI, and the AAPS/INTFG have been very active in the area of OINDP development, producing numerous documents to help clarify current thinking on many of the tests and approaches that should be used. Hence, it is highly recommended to maintain awareness of emerging developments in this area.