The Chinese Food and Drug Administration on Tuesday said that clinical data from four Taiwanese hospitals can be used when applying for drug permits in China, a “breakthrough” that industry leaders said would give Taiwan a leg up in developing into an Asia-Pacific hub for pharmaceutical research and trials.
The Institute for Biotechnology and Medicine Industry said the announcement would cut costs for drug developers on both sides of the Taiwan Strait, as the new policy would reduce overlapping trials and shorten the timeline for getting new drugs onto the market.
“This is great news, at least for a company like mine, which conducts clinical trials on both sides of the Strait,” said Hsu Ming-chu (許明珠), chairwoman and chief executive of TaiGen Biotechnology Co, a research-based and product-driven pharmaceutical company.
Her company is conducting third-phase trials of Taigexyn, an anti-infection drug, that need more than 500 patients — a big number that she said would be difficult for just eight hospitals on both sides of the Taiwan Strait to fulfill.
Under an agreement between Taiwan and China, four hospitals in Taiwan and four in China will be “bases” for mutual recognition of their trial records. The four local hospitals are Taipei Veterans General Hospital, Tri-Service General Hospital, National Taiwan University Hospital and Chang Gung Memorial Hospital in New Taipei City’s Linkou District (林口).
The four Chinese hospitals are Peking University First Hospital, Beijing Union Medical College Hospital, Shanghai Jiaotong University’s Ruijin Hospital and Shanghai Fudan University’s Zhongshan Hospital.
Hsu said that she hopes more hospitals will be included under the program.
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