China’s Center for Drug Evaluation (CDE) under the State Food and Drug Administration (SFDA) has recently released statistics for CDE drug registration approval recommendations in 2008. The CDE reviewed over 25,000 applications, including those for clinical trials, import, and production, but rejected over 60% of them. The CDE reviews applications and then submits their recommendations for approval or rejection to the SFDA, who grants the final approval.
The results for foreign imported drug registration applications were as follows:
581 imported drug registration applications were approved by the CDE, which included import registration, supplemental applications, and clinical trials. This was about 37% of total imported drug applications and covered 215 specific chemical substances or compounds. Of these, 276 of the 581 applications were approved for clinical trials. Also, 44 applications were approved for import. 261 supplemental applications were also approved.
The results for locally-manufactured drugs were as follows:
710 registration applications (42%) were approved for clinical trials. Of these, 434 of the 710 applications were approved for clinical trials, and 276 applications were approved for bio-equivalence studies.
There were also 1,595 local drug registration applications that received production approvals from the CDE. Of these, 633 applications were recommended for new drug approval (40%), and 962 applications were approved as generic drugs (33%).
There were also 1,252 supplemental registration applications approved for local drug products.