China—A Challenging Regulatory Road but Promising Signs are Ahead
Posted 01 November 2009 | By
Imagine your salt shaker is empty and you cannot remove the lid. This shaker, however, has been in your family for decades, thus you cannot casually discard it-you have to refill it. So you pour salt over the lid in the hope that with enough time and patience, sufficient grains will find their way through the tiny holes to ultimately refill the shaker. Any pharmaceutical company trying to incorporate China into its global product development plans is likely to identify with this analogy. If the goal is to support global clinical trial enrollment, by the time you receive regulatory clearance in China the study might be nearly completed. And if it is to secure registration in China, the study's Chinese population is short of satisfying the China State Food and Drug Administration's (SFDA) patientnumber requirement. There has to be an easier way! Fortunately, promise is on the horizon. Industry continues to move in the right direction to work constructively with China in reforming its regulatory framework, and the Chinese government is responding.