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Time: October 6, 2016 (Thursday)

Place: TRPMA Conference Room

Time: October 6, 2016 (Thursday)

Place: TRPMA Conference Room

TRPMA invited Ms Li-Wen Chang, senior clinical research director of TaiGen, to give a talk on the company’s experience of conducing new drug R&D and NDA in China based on the success of Taigexyn, Taiwan’s first NCE product. Ms Chang explained in detail about the company’s successful experience in obtaining market authorisation and launching Taigexyn in China.

Taigexyn obtained the market license from the TFDA in January 2015 and the license from the CFDA in June 2016. So far, it is the only Taiwanese product that has been licensed in Taiwan and China.

Ms Chang shared TaiGen’s experience with the audience. She pointed out that the application of the US FDA IND helps manufacturers to formulate clinical research protocols which are likely to pass the IND review in other countries. Ms Chang also reminded the audience to understand the NDA procedure and to make good use of the advisory services so as to avoid any delay in the process.

The drug review and approval system in China has gone through a major reform. CFDA are determined to establish an efficient and transparent R&D environment. Taigexyn was one of the new drugs pioneering and obtaining the CFDA license through self-assessment. It shows the potential of Taiwanese drug manufacturers.