Taiwan: The Clinical Trials Gateway to China?

TaiwanTaiwan sits, along with its smaller counterparts, Singapore and Hong Kong, as one of the gateway countries to running a clinical trial in China. Although Hong Kong’s regulatory ties are more formalized with China, than Taiwan, Taiwan has the right environment and population to make the possibility of greater regulatory cohesion with its giant neighbour, not such a distant possibility, representing a huge opportunity for sponsors looking to break into the China market at some point. Taiwan, as a country, is not too large and not too small. It has a good health system and a population that has shown a cultural tendency towards adherence to medication and open participation in trials. There is the added bonus of its growing middle-class and with that, high literacy rates of its population. The country’s geographic location also makes it a highly desirable location due to its position as an autonomous satellite country to the east of China’s Fujian province.

Taiwan has a population roughly half that of its northern neighbour Korea. At 23.5 million, Taiwan is larger than the populations of Hong Kong and Singapore combined. GlobalData estimates the Taiwanese pharmaceutical market to be approximately $5.4 Billion in 2013 and is expected to grow to $8.4 Billion by 2020. These figures, in conjunction with a semi-universal healthcare system, supported by payroll tax, provides fertile opportunities for the country and its populations to engage in clinical trials.

George Clinical, a leading CRO in Asia, has over fifteen years’ experience conducting trials in and around Taiwan and China. They speak with a high degree of optimism about the future of clinical trials in Taiwan, especially following the mutual acceptance of clinical trial data agreement between the Institute for Biotechnology and Medicine Industry (IBMI) and their counterparts in China, the China Food and Drug Administration (CFDA).

The agreement which was heralded by the IBMI as ‘… one big step forward after the cross-strait cooperation agreement for medicine and public health affairs signed between the two regions in 2010,’ will take effect from April 25, 2016. The May 2nd press release from the IBMI goes on to say that the:

“…clinical trial data provided by four Chinese hospitals – Peking Union Medical College Hospital, Peking University First Hospital, Shanghai Zhongshan Hospital and Shanghai Ruijin Hospital – can be used to apply for a New Drug Application in Taiwan, while China will also accept NDA filings using clinical trial data provided by four hospitals in Taiwan – Taipei Veterans General Hospital, Tri-Service General Hospital, National Taiwan University Hospital and Linkou Chang Gung Memorial Hospital. Previously, repeated clinical trials were required in each region to gain local NDA approval.

This collaboration is only the first step towards an inevitable symbiosis between the population and geopolitical powerhouse, and its smaller (and perhaps more nimble) cousin. It could have the added benefit of enhancing the quality of the data that is collected both in China and Taiwan, and subsequently improving the speed at which a drug or device can reach either market.

Philip Gregory, the Managing Director of George Clinical, China, is quick to offer his support for the strengthening of regulatory and data sharing between China and Taiwan.

“George Clinical has managed a number of successful clinical trials in both China and Taiwan over a number of years,” Mr Gregory said. “As the costs of running a clinical trial continues to escalate, Asia represents a fantastic option to deliver robust data on time and within budget. Saying that, it is always of considerable interest when two of our key countries decide to increase ties to streamline the clinical trial processes for both CROs and sponsors. We welcome this move by the IBMI and the CFDA as it represents a move in the right direction for a sector and a region that embraces progressive actions to bring about greater efficiencies.”

So is Taiwan the clinical trials gateway to China? Perhaps, not yet. Though with greater collaboration, the future is definitely bright for the clinical trials sector in Taiwan.


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