Tuesday, June 5, 2007

Make your move: Taking Clinical Trials to the Best location

In a recent article on the Pharma Focus Asia website, China was considered as the number one place in the world to outsource to in the pharmaceutical industry. This comes at a time when a majority of companies in the pharmaceutical industry are looking for cheaper prices and greater profit.

China takes the top spot: China is unquestionably among the most attractive markets for performing clinical trials. With the largest urban population in the world, the country provides a vast patient pool and a large infrastructure of hospitals. China also has close to 1.4 million doctors and more than a million nurses and technicians. Their low salaries, in part, mean that conducting a trial in China could cost about half of what it would cost in the United States.

China is attractive to pharmaceutical companies—with some estimates suggesting that the country could overtake the United States as the world's largest market by 2020. AstraZeneca opened its East Asia Clinical Trial Center in Shanghai in 2003, but others have been slow to follow.

To encourage more foreign companies to conduct clinical trials in China, the government has passed new regulations and is establishing clinical practice centers to train investigators and staff. Although only hospitals designated by the Chinese State Food and Drug Administration (SFDA) can conduct trials, principal investigators from these institutions often have extensive experience with Western companies, making for a smoother process.

Still, China has its drawbacks. Bureaucracy and strict government regulations pose ongoing risks for companies. For example, gaining approval from the SFDA to conduct a trial can take nine to 12 months, and companies must acquire a drug import license for every shipment that enters the country, rather than one for each type of drug. The country continues to suffer from a weak national infrastructure and sporadic enforcement of intellectual property rights. Cultural and language differences are costly and can slow the process. For example, researchers continue to record data in Chinese, which increases costs for translation and causes further delays.

To view the entire article at its original location click on the title of this post.

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