Changing Regulations May Broaden CMO Market Opportunities in China, Russia, India


Changing regulations in the developing world could indicate an expanding market for CMOs in emerging markets. Chief among these is a three-year pilot program in China aimed at increasing registration of new products with the China Food and Drug Administration (CFDA), which could lead to growing demand for clinical and commercial contract manufacturing services.

The current Chinese drug approval system requires that pharma companies seeking CFDA approval for new products must own a GMP-compliant manufacturing company to make the drugs. The pilot program began Dec. 1 in 10 provinces and municipalities. Narcotic, psychotic and radioactive drugs, along with medicinal toxics, preventive biologics and blood plasma products are excluded.

This article is reprinted from the December issue of Emerging Markets Outsourcing Report. The full article addresses the changing regulations in China, Russia and India. To learn more, click here.

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Jim Miller is the founder and president of PharmSource Information Services, Inc. A preeminent expert in bio/pharmaceutical outsourcing, Jim established and presides over the industry’s principal resource for serious consumers of information on contract drug development and manufacturing, PharmSource STRATEGIC ADVANTAGE. He is editor and publisher of Bio/Pharmaceutical Outsourcing Report and Emerging Markets Outsourcing Report.

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