ABSTRACT
With respect to chemistry, manufacturing, and control (CMC) issues, the global regulatory landscape for pharmaceutical inhalation aerosols has become a complex web of rules, requirements, and specifications managed by a wide range of governing and advisory bodies. This structure borrows heavily from older delivery technologies and struggles to keep up with rapidly evolving scientific knowledge and innovations which blur the domains of pharmaceuticals and medical devices. The drivers of this situation have been primarily the United States FDA and European Union health authorities both centralised (European Medicines Authority, EMA) and decentralised (individual member states). However, growing markets outside this sphere are now adding to the web. Each regulatory body brings different views and legal mandates regarding risk management, control of product quality, assessment of bioequivalence, and generic substitution. This chapter traces the evolution of current landscape and uses that framework to extrapolate to likely regulatory trends over the next 5 years–7 years.
