Chapter 15 - Regulatory Considerations for Aerosol Therapy
Chapter 15 Regulatory Considerations for Aerosol Therapy
by Svetlana Lyapustina, PhD and David Cipolla, PhD
In all developed and in many developing countries, medicinal products, including medicinal aerosol products, must be approved by an appropriate government agency prior to marketing authorization. Knowing and complying with the requirements of an appropriate regulatory agency (or agencies) is a prerequisite to successful commercialization of any aerosol therapy. The range of governmental regulatory oversight is broad, including manufacturing site inspections, review of preliminary data and study protocols before the start of trials in human subjects, review of the sponsor’s clinical and in vitro data for the proposed product, approval of final labeling, review of post-approval changes to any aspect of the product or manufacturing process, monitoring of adverse event reports, and other areas.
