China FDA Proposes New Rules to Speed Foreign Drug Approvals

China's FDA is circulating a draft proposal that would speed up China approval of novel foreign drugs. Under the new rules, if a drug's IND is already approved in another country, it would be exempted from filing a China IND/CTA request before starting China clinical trials. The change has important implications for multinational global trials. The new rules would allow a pharma to implement a China arm of a global trial without waiting for the CFDA to approve an IND/CTA. Because IND/CTA approvals can take as long as two years in China, China was often not included in global trials, as pharmas could not afford to put large, important trials on hold while they waited for the CFDA to issue an IND/CTA ruling. More details....

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