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SFDA To Use Third-Party Verification For New Drug Approval

This article was originally published in PharmAsia News

Executive Summary

To improve crackdown on counterfeit drugs, China's State FDA has recently tried out third-party verification for new drug approval. According to the agency, a third-party organization detected western medicine components in a TCM drug sample which was submitted for new drug license application, leading to the decision that the treatment effectiveness was false. SFDA has implemented stricter approval for high-risk medicines such as TCM injections, multi-component biochemical injections, high-volume chemical injections and biological products after the frequent occurrence of injection safety incidents in recent years. Furthermore, because previous drug approval procedures mainly check applicant's documents, some companies even fake clinical trial data for new drug licenses. SFDA is considering implementing third-party evaluation and verification to overcome its technical and facilities limitations, as well as to ensure objectivity. (Click here for more - Chinese Language)

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