First CROs selected for China’s express customs scheme

According to a recent Business Insights report China’s contract research sector is growing 13 per cent a year and will be worth $12.3bn in 2011, driven by pharma industry demand for treatment naïve population and vogue for outsourcing.

This rapid growth has increased the number of contract research organisations (CROs) importing clinical candidates, causing customs clearance to emerge as a significant bottleneck, which is bad news for a sector where timelines are critical.

In April the Chinese government acknowledged the detrimental impact such delays can have on Chinese CROs and mooted an express clearance programme as part of a wider policy to encourage further growth of the outsourcing sector.

Under the pilot scheme the three firms, all of which are based at Shanghai’s Zhangjiang Hi-Tech Park, can use a number of measures, including pre-declaration and 24-hour review protocols, to expedite the importation process.

A Sundia spokesperson told Outsourcing-Pharma that: “In principle the control and inspection procedure is the same as before, the difference is that the customs pay special attention to the CRO shipping to make sure its is not delayed.​

“Many clients are concerned about the delay at customs. Now they will feel more comfortable to contract projects to CRO companies who have got express clearance treatment​.”

Expansion plans​

If successful the scheme will be rolled out to other CROs headquartered in Zhangjiang, based on a review of the individual company’s internal management system, track record and reputation.

While the Chinese CRO sector is still a relatively small part of the global clinical trials market it has grown considerably as a result of the Asian pharmaceutical outsourcing boom.

More recently however other regions like South America and central and Eastern Europe (CEE) which, like China, both have large, treatment naive potential trial populations have begun to compete with Chinese CROs.

Clearly the Chinese government’s accelerated customs clearance scheme is designed to swing the pendulum back in favour of local CROs, although whether the strategy will provide the boost the industry needs remains to be seen.

Any strategy that helps CROs cut development times is likely to be welcomed by the drug industry. A recent survey of pharma firms by Cutting Edge Information ranked the ability to hit deadlines as the critical factor in selecting a development partner.