To enhance the management of laboratories for drug clinical trial biological sample analysis, and improve the quality and management of analytical data of biological samples, the State Food and Drug Administration (SFDA) recently formulated and issued the Guidance on Management of Laboratory for Drug Clinical Trial Biological Sample Analysis (interim), in accordance with the Provisions for Drug Registration, the Good Clinical Practice (GCP) and the Good Laboratory Practices (GLP) for Non-Clinical Laboratory Studies and referring to international norms.