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Talk of the Day -- Big breakthrough in new drug development
Central News Agency
2013-12-02 11:22 PM
Taiwan will form an alliance with 11 countries on cooperation in evaluating "bridging studies" to help expedite the registration of new drugs, according to the Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare. Under the new partnership, participating countries will agree to assess the acceptability of extrapolation of foreign clinical data to a new region to speed up the process of having the drug win approval in the local market. Describing the cooperative project as a biological free trade deal, the TFDA said the new alliance, if formed, would mark the biggest breakthrough in international biotech cooperation in two decades. An initial consensus on the new alliance was already reached at two international biomedical conferences held in Taipei last week, the TFDA said. The following are excerpts from a special report in the Monday edition of the Economic Daily News on the new development in the biotech sector: The 11 countries that have tentatively agreed to join the free trade agreement (FTA) with Taiwan are the United Kingdom, the United States, Canada, Japan, South Korea, Singapore, Malaysia, Thailand, New Zealand, Indonesia and China. The formation of the "bridging studies" alliance could usher in an FTA era in the biotechnology sector, which has been estimated to offer US$1 trillion worth of potential commercial opportunities. All of the 12 countries sent representatives to a seminar on cooperation in extrapolation of foreign clinical data in new drug development and an APEC symposium on orphan drug development. Both conferences were co-sponsored by TFDA, the International Pharmaceutical Federation (FIP) and the American Association of Pharmaceutical Scientists (AAPS). Hu You-pu, an Examination Yuan member who once headed the TFDA's precursor Drug Administration, served as convener of the two conferences. After three days of discussion, representatives agreed that a new drug that has been marketed in any of the 12 countries will just be required to pass pharmacokinetics (PK) and dose response curve tests before being marketed in the alliance's other member countries, Hu said. The agreement will save US$60 million to US$100 million in clinical test expenses and will advance the time for developers to reap profits by three to five years, Hu said. Hu, a FIP vice chairman in charge of rules and regulations, said clinical tests tend to be seen as a major barrier to international pharmaceutical trade. "The agreement to remove such a barrier marks a big step forward in biomedical trade liberalization," Hu said. But he acknowledged that more effort needed to be made to put the proposed agreement into practice. First, he said, the FIP should endorse the proposed agreement reached at the Taipei conferences that concluded Nov. 30. Second, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has to revise regulations related to evaluation of "bridging studies" to facilitate implementation of the pact. "We hope all 12 member countries will be able to finalize their domestic legal revisions or enactment of new decrees to smooth the way for the proposed agreement," Hu said. Meanwhile, it was also agreed during the three-day meeting that the 12 countries will form a collaborative platform for development of orphan drugs. Seven to eight Taiwanese biotech firms, including SyneuRx, PharmaEssentia Corp. and Medigen Biotech Corp., are developing various orphan drugs, Lin said. (Dec. 2, 2013). (By Sofia Wu)
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