George Clinical welcomes The Taiwan Food and Drug Administration’s (TFDA) recent clarified timelines for approval of a general Clinical Trial Authority (CTA) at 45 calendar days. The announcement, released by the TFDA in October, adds to the suite of attractive options to expedite clinical trial regulatory approval timelines in Taiwan. This includes the existing 15 calendar day multi-regional clinical trial (MRCT) fast-tracked approval timeline for sponsors with existing regulatory authority approval from any of the following countries: Germany, United States, United Kingdom, France, Japan, Switzerland, Canada, Australia, Belgium or Sweden.
“The TFDAs announcement of their general CTA timeline is yet another pragmatic move by the Authority to make Taiwan an attractive addition to MRCTs,” stated Evon Hui, Head of Business Operations, East Asia. “George Clinical has more than six years’ experience working in Taiwan. With the 15-day conditional approval and a swift central ethics process further reducing start up times, Taiwan should be considered a top tier country for sponsors considering their site mix and regional strategy.”