Foreign media: Over the past decade, China's biopharmaceutical industry has rapidly risen, but still faces the gap between China and the United States and geopolitical obstacles. In 2015, China required all ongoing drug clinical trial data to be self-inspected, with a one-month deadline for withdrawal without penalty, but those who concealed or falsified data would face severe punishment. As a result, 79% of the ongoing applications were withdrawn, reflecting serious problems in the industry at that time. This reform became a turning point, enabling China's drug regulation to gradually align with international standards, shifting from a focus on generic drugs to encouraging innovation.
Since then, the credibility of China's pharmaceutical regulatory system has approached Western levels, laying the foundation for the development of local biotechnology companies. Research shows that the proportion of Chinese clinical data receiving a "no further action" rating in the U.S. FDA evaluation has significantly increased.
Despite this, the United States started the industry earlier and has accumulated deep expertise, and Sino-U.S. trade friction and tariff barriers may limit the global competitiveness of Chinese enterprises in the short term, but long-term trends show that China is rapidly catching up.
Original article: www.toutiao.com/article/1842502275678215/
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