Challenges ahead

According to Liu, a great challenge comes from TCM itself, as traditional TCMs are typically a mixture of diverse compounds, making it difficult to explain how they work and to standardize the dosage, among other things.

Assessing effectiveness and ensuring safety are also issues that have inhibited multinational companies' significant engagement with TCM and its global expansion so far.

"It's often hard to market TCM in many other countries because of the difficulties of explaining its working mechanisms and extracting its effective ingredients," said Zang from GSK, adding that his company will transform TCM from an experience-based practice to evidence-based medicines through innovation and differentiation.

TCM is a well-established system of medical practice developed through thousands of years of empirical testing and refinement of herbal mixtures, and relies on clinical experience. 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.

"What we will do is to transform the TCM's mechanism into clinical data and evidence through Western methods," said Zang.

Many measures have been used in developing TCM products, and one is to extract the effective ingredients from TCM and form a new compound drug.

"We don't do it like that, and we still abide by the concept of TCM," Zang said. "We will test the effective ingredients of TCM, and see how they work and form through innovative means."

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.

"Drug discovery takes time, money and more importantly, perseverance, TCM or not. We should not be shortsighted and expect quick results," Liu said.

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.

Contact the writers at liujie@chinadaily.com.cn and wanghongyi@chinadaily.com.cn

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What is TCM?