News and Insights
Growing Regulation in Developing Markets: Trends and Implications
The Appeal of Clinical Development in Emerging Markets
A growing number of clinical trials are being conducted in emerging markets (i.e., China, India, Southeast Asia, and certain Latin American countries) in order to generate data for product submissions in both the US and developing markets. Pharmaceutical and medical device companies often pursue product approval in emerging markets with lower regulatory hurdles as an entry strategy for products they would ultimately like to launch globally. In doing so, they can ensure early market entry, gain valuable clinical experience, work towards market expansion, and improve on their technology before entering larger markets where they likely face higher regulatory burdens.
The advantages of using data from clinical studies in emerging economies for US product submissions include cost savings, ease of patient recruitment, and the ability to conduct larger trials in less time. Also, FDA oversight of clinical trials in emerging markets has been minimal to date, adding to the appeal of this strategy.
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