Core Viewpoint - Shenzhen Customs has issued the first "white list" approval for special biopharmaceutical items to Mindray Bio-Medical Electronics Co., Ltd, facilitating the import of critical raw materials for in vitro diagnostic reagent production, marking a significant step in the implementation of a joint regulatory mechanism for biopharmaceuticals in Shenzhen [1][2]. Group 1 - The approval allows Mindray to import 61,000 milliliters of serum quality control and standard products, which will meet the production needs for the next seven months, resulting in an estimated output of 12,000 reagent kits valued at approximately 7 million RMB [1]. - The new joint regulatory mechanism streamlines the approval process, allowing companies to handle applications through a single window, significantly improving efficiency compared to the previous multi-departmental process [1][2]. - Quality control and standard products are essential for the development and production of in vitro diagnostic reagents and instruments, directly impacting the accuracy and reliability of test results [1]. Group 2 - Currently, 13 enterprises have been included in the first batch of the "white list," with nearly 500 products in the pilot program, and over 4,000 biopharmaceutical enterprises in the city eligible to apply [2]. - An expert database has been established in collaboration with various municipal departments to conduct embedded assessments of enterprises' biosafety management systems, optimizing the approval process to enhance efficiency by an estimated 70% [2].