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Entering the Chinese market has just become easier as cross-strait cooperation bears fruit

Oct. 3, 2016

Taiwan's strategic focus on biotechnology, its GCP-compliant professionals, global outlook and widely respected FDA, are some of the reasons why the country has long been a vibrant and sought-after location for contract research.

Now there is another reason. The Cross-strait Cooperation Agreement on Medicine and Public Health Affairs, concluded in 2010, is starting to produce tangible benefits. Four hospitals on both sides of the Strait of Taiwan have mutually recognized the results of clinical tests conducted by the others. This is the first set of trials to be mutually recognized, and clearly points in the direction of further cooperation. The treatments can now be prescribed without the need for further clinical testing in the other territory, shortening time to market by an estimated three years.

Taken together with the recent Economic Cooperation Framework Agreement (ECFA), which allows medical services and products approved in Taiwan to be sold on the mainland, the implications for global manufacturers are significant. Taiwan is now literally the gateway to China.

While proximity and identity with China are a strong attraction, Taiwan’s vibrant biotechnology and pharmaceutical sector is not based solely on geography. Since determining in 2007 that biotechnology and biopharmaceuticals were of strategic importance, Taiwan has made a determined effort to devote resources, and to attract and develop expertise. The valuation of Taiwan’s biotechnology companies has increased seven-fold over this period.

Hand-in-hand with strengthening its science base, administrative and regulatory reform has also encouraged development. In its fast-track process, approvals issued by any of 10 reference countries require only an administrative review. In addition, ethical and regulatory reviews can be conducted in parallel.

Taiwan's achievements and further potential were on display at BioTaiwan2016, Asia’s largest biotechnology exposition now in its 15th year. One of its star performers in 2016 was the pancreatic cancer treatment Onivyde, developed by a small Taipei-based company, and approved in 2015 by the U.S. FDA.

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