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  • 'China approves new drugs after completing trials in China'
  • by Lee, Tak-Sun | translator Kang, Shin-Kook | May 23, 2024 05:48am
Just after completing multi-regional clinical trials within the country
Jessica Liu, Senior Consultant at Tigermed introduces China¡¯s regulatory environment for drug approvals
Korea-China Bio Innovation Forum¡¦country operates an accelerated approval system for rare diseases rather than an orphan drug designation system
 ¡ã The Korea-China Bio Innovation Forum is being held in Hangzhou, China, from the 20th to the 22nd, with 25 Korean bio venture companies participating and meeting with more than 50 Chinese biotech and pharmaceutical companies

China's drug approval authorities grant first-in-class drug approvals to drugs as soon as their multi-regional clinical trials (MRCTs) in China are complete, regardless of whether they are approved by the U.S. Food and Drug Administration (FDA) or other national drug regulatory agencies.

Tigermed¡¯s Senior Consultant Jessica Liu responded so to a domestic pharmaceutical company's observation that Korea's Ministry of Food and Drug Safety (MFDS) tends to approve new drugs after referencing the situation of advanced countries, such as whether the U.S. FDA or European EMA approves them.

At the Korea-China Bio Innovation Forum hosted by Tigermed and Dream CIS in Xiaoshan, Hangzhou, China, on March 21, Senior Consu
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