China to Accept Foreign Clinical Trial Data for Drug/Device Approvals
China's State Council has issued a broad directive aimed at speeding up China's drug/device approval process, including using foreign trial data for approvals. The latest regulatory changes will join several other reforms instituted earlier this year, including speeded-up approvals for Phase I clinical trials, eased requirements for China participation in global clinical trials, expanded use of the expedited Green Channel approval process, and the use of CMOs to manufacture biologic drugs. Each of these was a significant modernization; together they represent extraordinary change. More details....
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Original Article: China to Accept Foreign Clinical Trial Data for Drug/Device Approvals
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