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Contrasting Inhaled Drug Product Registration in Asia with USA and Europe

Purohit RN.

RDD Asia 2016. Volume , 2016: 145-154.

Abstract:

The Asian continent contributes more than half the population of the world. Most Asian countries are registering significant economic growth rates as a result of substantial industrialization, urbanization, and growth in per capita income. These changes are resulting in the increased prevalence of pollution-related and lifestyle diseases such as asthma, chronic obstructive pulmonary disease (COPD), and diabetes, making Asia an increasingly attractive market for the pharmaceutical industry.

Cultural, geo-political and economic differences among Asian countries are reflected in the pharmaceutical regulatory framework of each country resulting in significantly different regulatory expectations. The Association of South East Asian Nations (ASEAN) has made an attempt to harmonize the regulations across the region, but participating countries are still in the process of working out their differences before a common framework becomes a reality.

The evolving orally inhaled product (OIP) regulations in Asia are effectively the result of regional practices coupled with the fact that OIP technology is still in its infancy in most parts of the continent. This paper is an attempt to analyze the similarities and differences in OIP regulations across Asia in general, and South East Asia in particular.