Hey ahjay,"Under the new guidelines, foreign sponsors could start Phase I studies in China simultaneously with Phase I studies conducted outside China," Zhang said.
Multiregional clinical data accepted
CFDA would also allow foreign companies to use multi-regional clinical trial data to support new drug applications in China as long as the trial design fits China’s technical guidelines. This means that companies would no longer need to conduct a second local trial in China after running their global trials.
News: PRR Prima BioMed says clinical studies of IMP321 are progressing well, page-16
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