China accepts 4 Taiwan hospitals' clinical data for drug permits - Focus Taiwan

China accepts 4 Taiwan hospitals' clinical data for drug permits

NTU Hospital. (CNA file photo)
NTU Hospital. (CNA file photo)

Taipei, April 26 (CNA) China's Food and Drug Administration announced Tuesday that clinical data from four Taiwanese hospitals can be used when applying for drug permits in China, a "breakthrough" that industry leaders said will 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 will cut costs for drug developers on both sides of the Taiwan Strait, as the new policy will 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, chairwoman and CEO of TaiGen Biotechnology Co., a research-based and product-driven pharmaceutical company engaging in the development of novel therapeutics for infectious diseases, cancer and diabetes.

Her company is conducting third-phase trials of Taigexyn, an anti- infection drug, that needs 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 hospitals in Taiwan are Taipei Veterans General Hospital, Tri-Service General Hospital, National Taiwan University Hospital and Chang Gung Memorial Hospital in Linkou, New Taipei.

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, whose company has a wholly owned Beijing subsidiary with a proven capacity to conduct clinical trials and related registrations, said she hopes more hospitals will be included in the list of hospitals under the data acceptance program.

The Institute for Biotechnology and Medicine Industry called the latest announcement from China "an important beginning" in cross-strait cooperation on clinical trials.

To speed up cooperation in this area, the institute said it will hold a briefing in June for the medical industry and invite experts from all eight hospitals to jointly map out procedures for biomedical companies to apply for permits on joint clinical trials.

(By Han Ting-ting and S.C. Chang) ENDITEM/J

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