China Steps Up Efforts to Control Pharma Supply Chains



Pharma IQ
02/25/2011

China is again and again cited as rapidly becoming one of the most important global centres for the pharmaceutical industry. The country's market is expected to grow by 25 to 27 percent this year, according to IMS Health, and is now the third largest in the world.

Among the companies looking to step up spending in China is Roche, which plans to establish more diagnostic and research and development operations in the country in the coming years.

Cancer drug developers are also seeing China as a key market, and South Texas Accelerated Research Therapeutics (START) last year announced it would be opening a facility in Shanghai for conducting phase I trials of innovative cancertherapies.

Walter Lau, managing partner for Cenova Ventures, which is collaborating with START on the project, said: "We expect many future innovations in the pharmaceutical industry will come from clinical development in China."

Logistical factors

It is thanks in part to its large patient pool and supply of cheaper labour that China is emerging as a key centre for conducting clinical trials, however it still lags significantly behind the established markets in the United States and Europe.

One of the reasons behind this, according to a recent report on Globalisation by the Association of Clinical Research Organisations, is clinical trials in China may not always be as cheap as companies might think.

"The cost per patient in India and China has been estimated at one?third of that in the United States.

"Although per patient costs are lower, when logistical and other factors are considered, the fully?loaded cost of conducting studies in developing countries often approaches levels that would be found in more established areas," the report said.

It claims time to market is the largest advantage these regions can offer, meaning clinical trial supply systems and the regulatory environment are equally key considerations alongside cost.

In the past China has also had issues with the supply of active pharmaceutical ingredients, in particular relating to the oversulfated chondroitin sulphate, which was provided to herapin producers and led to a number of deaths in the United States.

Chondroitin sulphate is not used for production of heparin, but under clinical analysis looks like the API.

The compound used was traced back to a facility in China, which acquired it from an unregulated firm, and this led the country to step up efforts to control such supply chains, by creating a system allowing a raw material to be traced back to the source.

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