Drug Testing in China

With the world’s largest population and an immense pool of untreated patients, many who qualify for various clinical testing, China poses an attractive prospect for pharmaceutical companies. US drug manufacturers are realizing the untapped potential of testing in China. Most importantly, costs to conduct testing in China are considerably lower than in the US. In addition, some larger drug companies are being drawn to China to conduct further research even after the approval of the drug in the US.

However, many smaller companies are taking advantage of the lower costs of testing and conducting their initial studies in China to help shape their research in the United States. NexMed Inc., a drug start-up (produces Alprox-TD® alprostadil cream for male erectile dysfunction) in New Jersey is one of these small companies. NexMed’s Chief Executive, Joseph Mo, was quoted in the Asian Wall Street Journal saying, “Before we invest US$20 million we want to make sure it works. For a big company it’s nothing, but for us it’s a lot of money.”

Regulations governing drug testing in China are still in the early stages of development. Thus, requirements to start a research trial may be tedious. There are also concerns on the part of many drug makers that testing conducted in China would not produce results on par with testing quality in the US. However, the future possibilities of testing drugs in China have not been entirely discounted. FeRx, a drug maker based in San Diego (Developing drugs for liver, brain, and lung cancer), became the first company to receive approval from the State Drug Administration on May 22, 2001 to run clinical tests of an investigative drug not already approved in the US.