Perspectives on the Evolving Regulatory Landscape for Inhaled and Nasal Products
Peri P, Purrington AM, Lyapustina S, Evans J.
Respiratory Drug Delivery 2022. Volume , 2022: 175-186.
Abstract:
The global regulatory landscape for orally inhaled and nasal drug products (OINDPs) is evolving to meet the continued medical need for treatment of asthma and chronic obstructive pulmonary disease (COPD) as well as addressing unmet needs for other respiratory diseases. The COVID-19 pandemic has had a significant impact on respiratory health accelerating the development of new therapies. Utilization of new digital technologies such as mobile applications and sensors within products enabling remote patient monitoring by health care providers (HCPs) and caregivers, implementation of patient centric drug development, and progress towards environment friendly and sustainable solutions for developing products have also influenced the regulatory landscape. Advancement in new quality requirements and standards globally by various pharmacopoeias are impacting the regulations and guidance documents from health authorities. This article provides an overview of current trends in regulations and government policies influencing the development of OINDPs. Regulatory updates concerning clinical trials, generic inhalation products, devices and combination products development and registration of new products and, pharmacopoeia and standards for inhalation products are described.
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