"Turning point" of new drug application in Shandong Province

Recently, it was learned from the food and Drug Administration of Shandong Province that in 2014, there were 399 new drug applications accepted and examined in Shandong Province, an increase of 122 over the previous year, a record; 253 generic drug applications were accepted, a decrease of 24 over the previous year The number of innovative drugs exceeded that of generic drugs for the first time The number of new drug applications ranks the second in China Last year, Shandong Provincial Bureau of polysaccharide Analysis Office of Shandong polysaccharide drug Engineering Laboratory formulated and promulgated 10 systems, including procedures for speeding up the handling of drug registration in Shandong Province, meeting system for coordination of drug registration, working procedures for drug technology transfer, to speed up the process of drug registration At the same time, they further streamline administration and delegate power, and accelerate process reengineering Under the premise of ensuring no reduction in standards and no discount in quality, Shandong Provincial Bureau has delegated 19 drug registration and approval items, accounting for more than 50% of all drug registration and approval items Through work process reengineering, the working time limit has been shortened and the administrative efficiency has been improved In Shandong International Biotechnology Park, staff of Shandong Hairui Pharmaceutical Research Co., Ltd are conducting new drug research and development tests Shandong Provincial Bureau launched the development of drug registration information management system last year Through horizontal integration of the drug registration acceptance and review system, drug review management system and provincial hospital inspection management system, it vertically connects the drug registration acceptance and review system of the State Administration of drugs and establishes the drug registration and application system of the Municipal Bureau, so as to realize seamless connection of work processes; it also establishes the drug registration database, so as to realize drug registration Product registration supervision information query function At the same time, strengthen the supervision of drug research institutions, organize and carry out the special inspection of drug safety evaluation (GLP) institutions and drug clinical trial institutions (GCP), report the inspection results, rectify the existing problems within a time limit, and ensure that the drug research process is standardized, the data is true and the results are reliable At present, 328 clinical trial projects are undertaken by the provincial drug clinical trial institutions, and the drug safety evaluation and the construction of drug clinical trial platform show a good running trend "Shandong Provincial Bureau, acting actively, was authorized by the State Administration of drug technology transfer review Carrying out the evaluation of drug technology transfer is conducive to promoting the resource integration of pharmaceutical enterprises and promoting the transformation of pharmaceutical enterprises into modes and structures " Li Tao, director of the drug registration office of Shandong Provincial Bureau, said that as of December 31, 2014, Shandong Province had completed 319 applications for drug technology transfer from enterprises in the province, and the number of approved document numbers has accounted for about 30% of the total number accepted in the country Through the implementation of drug technology transfer, the concentration of new drug R & D achievements and production technology to the advantageous manufacturers has been accelerated, the enthusiasm of R & D and production of enterprises has been aroused, and the adjustment of industrial structure and optimization of product structure have been realized