Global drug launches held back by Chinese regulatory backlog - analyst
Shanghai. May 8. INTERFAX-CHINA - Multinational drug makers are
encountering snags in the Chinese drug registration process, which are
causing delays in their plans to launch new products globally, an
industry insider told Interfax yesterday.
"The primary obstacle to a simultaneous launch in China and other global
markets is that it takes the State Food and Drug Administration a lot
longer to finish clinical trial reviews than other national drug
regulatory bodies," said a senior official working for one of the
largest multinational pharmaceutical companies in China, who asked to
remain anonymous. "Where phase one clinical trials of a drug are just
beginning in China, in the United States, the drug may already be in
phase two or three trials."
There are several reasons behind the extended length of time it takes to
complete Chinese reviews for multinational-developed drugs, but one of
the chief causes is the large amount of generic drugs produced in China.
"Almost 60 percent of the human resources in the SFDA's Center for Drug
Evaluation (CDE) are devoted to reviewing clinical trial applications
for generic drugs," he said.
Clinical trials on generic drugs are not as extensive as that of novel
drugs. However, the CDE is required to complete reviews of generic
drugs, which are subject to shorter clinical trials, within a shorter
time frame than novel drug reviews. Hence, multinationals are finding
that their drug trials in China are being put on the back burner.
Earlier this week, Yang Zhimin, a CDE official, confirmed that an under-
staffing problem was contributing to the length of time it takes to
complete clinical trial reviews.
The anonymous official's solution echoed Yang's advice earlier this
week. "Multinationals would do well to hire staff to liaise with the
SFDA on what is required from Chinese clinical trials," he said, adding
that they could then work a global strategy around China's drug
registration process.
-CX
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