Western medicines are generally target-based small molecules or biologics, and their approvals for clinical use are based on clinical evidence of safety and effectiveness by staged clinical trials.
Assessing effectiveness and ensuring safety thus became issues that have inhibited multinational companies' significant engagement with TCM and its global expansion so far.
So far, the State Food and Drug Administration requires TCM manufacturers to follow clinical procedures similar to those required of their Western counterparts. For instance, three phases of clinical trials are required before a new product's approval. However, thorough implementation is impossible given the shortage of time and money, insiders say.
Novartis has spent more than three years on TCM R&D in China. The international drugmaker said it is not yet ready to answer questions related to progress in its ambitious plan announced in 2009.
"Drug discovery takes time, money and more importantly, perseverance, TCM or not. We should not be shortsighted and expect quick results," Liu says.