Zhongxin. com, Chengdu, April 11th (Reporter Liu Zhongjun) Sichuan Food and Drug Administration announced on the 11th that the first imported biological drug "cell model library" in the west has been built and put into use in Chengdu, Sichuan Province, and the supply chain service center of Chengdu Tianfu Biological City has completed the warehousing of the second and third batches of imported monoclonal antibody drugs "dabituo", which is more than 40% shorter than the previous customs clearance period of similar products.
It is understood that when "Dabituo" was imported through Chengdu Port before, the cell strain for testing needed to be purchased overseas, and there was a biosafety hazard in the process of international cold chain transportation. At the same time, drug import approval needs cross-departmental joint examination, and the customs clearance cycle is long, which affects the progress of drug listing. Under the guidance of Sichuan Food and Drug Administration, Sichuan Institute for Drug Control broke through a series of key technical bottlenecks, took the lead in establishing a "cell model library" for imported biopharmaceuticals in the west, continuously optimized the customs clearance process for imported biopharmaceuticals, and built a quality control platform for biopharmaceuticals that met international standards, providing a scientific basis for the rapid access of monoclonal antibody drugs such as "Dipituo" and "Tuoconsultation", and realizing the double improvement of inspection efficiency and accuracy of imported biopharmaceuticals.
In addition, the Sichuan Food and Drug Administration has continued to strengthen cooperation with Chengdu Customs, and promoted the establishment of a joint working mechanism between Sichuan Institute for Drug Control and Chengdu Customs Technical Department to realize real-time interaction of test data and collaborative risk control. At the same time, focus on the key links such as declaration, inspection and testing, optimize the workflow, realize the localized operation of the inter-provincial inspection process, create conditions for imported biopharmaceuticals to achieve "on-the-spot inspection", and vigorously promote the upgrade of the whole chain service of imported biopharmaceuticals.
The relevant person in charge of Sichuan Food and Drug Administration said that it will continue to rely on the "cell model library" to further expand the coverage of inspection categories, continuously deepen cooperation with customs and enterprises, and optimize docking services throughout the chain, so as to provide technical support for building the "Chengdu warehouse" of imported biopharmaceuticals and building a national biomedical industry innovation highland in Sichuan. (End)
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