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To maintain imports of bulk drugs and ensure consistency with the principle of domestic raw materials and drug registration approval, and to ensure the quality of imported pharmaceutical raw materials, the State Food and Drug Administration issued Notice [2004] No. 63 on March 16, 2004, revising the requirements for clinical research of national drug standards for imported chemical raw materials. For approved imports of bulk drugs intended for clinical research, a written application no longer needs to be submitted if clinical research is not being conducted. Instead, the necessary documentation should be gathered and forwarded to the Center for Drug Evaluation at the State Food and Drug Administration for technical review. For declarations of importing bulk drugs accepted before and after March 16, the State Food and Drug Administration will no longer approve clinical research documents based solely on technical review findings but will directly decide whether to approve the import registration of imported pharmaceutical raw materials based upon these findings.