Jiangsu Provincial Bureau strengthens its service function and achieves fruitful results

Since this year, the food and drug regulatory department of Jiangsu Province has continuously strengthened its guidance, standardization and service functions, and actively promoted the sustained, rapid and healthy development of the pharmaceutical industry In the first half of this year, the province's pharmaceutical industry above Designated Size achieved a total output value of 132.116 billion yuan, a sales revenue of 127.009 billion yuan, a profit of 12.403 billion yuan and a profit and tax of 19.824 billion yuan, up 21.05%, 18.91%, 20.5% and 20.3% respectively year-on-year, maintaining the national leading position in various indicators According to Jiangsu Provincial Commission of economy and information technology, in the first half of this year, Jiangsu's total output value of price medicine industry continued to lead the province's eight major industrial industries Since this year, Jiangsu food and Drug Administration of price province has successively carried out on-site office work in Taizhou, Lianyungang, Suzhou and other pharmaceutical industry bases, helping grassroots and enterprises face-to-face to solve the difficulties encountered in development The Provincial Bureau has set up the Suzhou Branch of the provincial medical device inspection institute in Suzhou to further facilitate business affairs and broaden the channels of technical consulting services We vigorously promoted the development of modern pharmaceutical logistics industry, approved 11 pharmaceutical third-party logistics enterprises in total, and actively carried out the pilot work of entrusted storage and transportation of medical devices and third-party logistics, with remarkable results Vigorously support the development of pharmaceutical R & D service outsourcing R & D service outsourcing institutions in Suzhou, Wuxi, Taizhou and other places have formed a agglomeration effect In the first half of this year, Jiangsu Provincial Bureau of price increased the implementation of newly revised GMP, established a system of follow-up, supervision and notification, printed and distributed the special issue on the implementation of newly revised GMP in Jiangsu Province of price, and timely reported the implementation of newly revised GMP in Jiangsu Province Carry out special investigation on eyedrop production enterprises, help enterprises to solve problems such as sterilization mode and validation of eyedrop bottles, solution preparation, transformation scheme of filling area, software upgrading of enterprises, etc.; organize 170 enterprise personnel and 30 supervisors to participate in GMP certification inspection training courses, and help enterprises and supervisors to understand the main characteristics of newly revised GMP certification inspection Jiangsu Provincial Bureau of price also held a joint meeting with Jiangsu Provincial certification and evaluation center to give full play to the technical support role of the center and help enterprises pass the inspection and certification as soon as possible These measures effectively promote the steady increase in the number of enterprises that have newly revised the GMP certification At present, of the 121 injection manufacturers in Jiangsu, 35 have obtained 46 newly revised GMP certificates issued by the State Food and drug administration, with a pass rate of 28.9%; of the 355 other drug manufacturers in the province, 112 have obtained 144 newly revised GMP certificates issued by the Provincial Bureau, with a pass rate of 31.5% It is another important measure for Jiangsu Provincial Price Bureau to promote the development of pharmaceutical industry in the first half of this year to make full use of the registration lever and increase the research and development of new drugs The Bureau strengthened its ties with research institutions and pharmaceutical manufacturers, intervened in the research and development of innovative drugs in advance, opened up green channels, and focused on improving the independent innovation ability of enterprises In the first half of this year, Jiangsu Provincial Bureau of price handled 2416 registration applications Among them, 322 applications for drug registration were accepted, an increase of 50.5% year on year In terms of application for innovative drugs, 33 applications for clinical trials of chemical drugs were accepted Next, the food and drug regulatory department of Jiangsu price province will strengthen the reform of the administrative examination and approval system, implement the centralized acceptance of all licensing matters, implement the system of first question responsibility and time limit completion, and provide convenient, high-quality and efficient services for enterprises Give full play to the role of various experts, inspectors, inspection and testing institutions and intermediary organizations, actively provide business training, technical guidance, quality design and other services for pharmaceutical enterprises, vigorously support the outsourcing development of pharmaceutical R & D services, support pharmaceutical enterprises to accelerate the "going global" step, and actively explore the international market We will vigorously promote the merger and reorganization of pharmaceutical and medical device manufacturers, and achieve intensive and large-scale development at a higher level We will further rectify and standardize the order of the drug market, carry out in-depth activities of "two strikes and two constructions" and "cracking down on counterfeit drugs and protecting famous brands", and earnestly safeguard the legitimate rights and interests of enterprises.