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Taiwan Agrees with 11 Nations to Speed New-drug Commercialization

2013/12/02 | By Quincy Liang

Taiwan's Food and Drug Administration (TFDA) of the Ministry of Health and Welfare recently announced that Taiwan has agreed with 11 nations to accelerate new-drug commercialization by simplifying clinical trials.

The 11 nations include the U.K., the U.S., Canada, Japan, South Korea, Singapore, Malaysia, Thailand, New Zealand, Indonesia, China etc., with the 12-nation alliance marking a new era for new-drug commercialization, TFDA claimed.

Two important international pharmaceutical-related annual meetings were held in Taiwan and jointly organized by TFDA, the International Pharmaceutical Federation (FIP), and the American Association of Pharmaceutical Scientists (AAPS), including the International Pharmaceutical Federation (FIP) Special Interest Groups (SIG) Regulatory Science Workshop "Harmonization of Bridging Studies among Asia-Pacific Region", and APEC Symposium of "Establishing a Regional Infrastructure to Facilitate the Accessibility of Orphan Drugs".

Oliver Hu, Minister without Portfolio of Taiwan and vice-chair of SIG, FIP, explained that the initial conclusions reached after the three-day international forums include commercialization of new drugs in the above-mentioned 12 nations after passing only two tests,  the pharmacodynamics and human-body dose-response curve studies,  without further opposing opinions. The simplified processes, Hu stressed, can cut the cost by US$60-US$100 million in clinical trials for each new drug, also enabling new-drug makers to start making profit  three to five years earlier.

The vice chair of the SIG said the alliance initially formed during the two international forums can be deemed as a "free trade agreement" in the global biotechnology industry.

However, Hu added, the initial consensus for the alliance would be further discussed in the 2014 FIP annual meetings, with the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) member nations to modify related regulations for clinical trials. Hu said that his goal is to complete all the work over the next three years, including seeing alliance member governments to promulgate related laws or administrative decrees.