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Guide: Guide the clinical research and development of litoxiin repellent biosimilar drugs in China! To guide the clinical development of biosimilars of rituximab injections in China, and to provide referencetechnical standards, the Drug ECDC, with the deployment of the National Drug Administration, organized the Guidelines for Clinical Trials of Lituxim-Statin-Injection Biosimilars (see annex).
In accordance with the requirements of the Notice of the General Division of the State Drug Administration on the Procedures for the Issuance of Technical Guidelines for the Issuance of PharmaceuticalS (No. 9 of THE Drug Administration(ICB) 2020), the State Drug Administration shall, upon examination and approval, be issued and shall come into effect from the date of publication.
hereby hereby notice.
Guidelines for clinical trials of litoxima-injectable biosimilars at the National Drug Administration's Drug Review Center on July 20, 2020. pdf.