Drug production supervision is stricter! 13 places with new moves

[China Pharmaceutical network industry trends] on March 30, an emergency Video Conference on work safety and food and drug supervision in Shandong Province was held in Jinan At the meeting, it was stressed that greater efforts should be made to strengthen the supervision of food and drug safety, strengthen the management and control of the whole process of food production and operation, do a good job in the investigation of food risks, severely crack down on "three no food" and fake and shoddy behaviors, and resolutely protect the "safety on the tip of the tongue" of the people Whether it's food or safety, it's related to people's safety Among them, drug safety is also the focus of social concern in recent years On March 13, the institutional reform plan of the State Council was released, which showed that considering the particularity of drug supervision, the State Drug Administration was established separately and managed by the State Administration of market supervision Hu Yinglian, a professor of the State Administration College, believes that this round of reform of food and drug regulatory agencies truly reflects the top-level design It is a new era for us to go beyond the Department to carry out reform and beyond the supervision to see safety This also means that the regulation of drugs will be more strict The author found that since 2018, in addition to Shandong Province's deployment of the food and drug supervision plan, 11 other provinces and 1 autonomous region have made corresponding plans According to the existing data, the author combed the following Recently, Heilongjiang Provincial Bureau issued the key points of drug production supervision in 2018, which clarified the overall requirements and tasks of drug production supervision in 2018 According to the work policy of strict prevention at the source, strict management in the process and strict control of risks, it is required to focus on five aspects: dealing with various risk problems in time, strengthening on-site inspection, carrying out special rectification of outstanding problems, strengthening team building, improving supervision ability and further improving the efficiency of government services It is reported that Henan Province will launch the annual activity of improving the quality and safety of drug production last year, on the basis of which, the provincial food and drug regulatory department will launch the action of improving the quality and safety of drug production in drug production enterprises to protect the drug safety of consumers Shaanxi Province It is reported that Shaanxi Provincial Bureau printed and distributed the key points of drug and cosmetics production supervision in 2018 While doing a solid job in daily supervision, it concentrated on the special rectification of raw and auxiliary material supply chain and Chinese herbal pieces, carried out special inspection on injection quality and safety, carried out special inspection on the safety and effectiveness of multi-component biochemical drugs, carried out special inspection on the legal source of Chinese herbal extracts, and launched the We will carry out the reliability verification of exhibition data, the special inspection of medical institutions' preparations, and the seven special inspections of cosmetics manufacturing enterprises to comprehensively promote the quality improvement of pharmaceuticals and cosmetics in the province In addition, the author also learned that in order to further prevent and control the risk of drug quality and safety, and implement the main responsibility of drug quality, Shaanxi Province will implement the quality and safety responsibility interview system of drug manufacturing enterprises On March 16, Fujian food and Drug Administration held the 2018 provincial drug production supervision conference in Fuzhou   The meeting pointed out that in 2018, Fujian Province will continue to carry out "wind prevention action 5" and "wind pursuit action 2", further strengthen the supervision of the quality of Chinese herbal pieces, investigate and deal with a batch of production of fake and substandard drugs in accordance with the law; focus on the special inspection of the supply chain of raw and auxiliary materials, focus on investigating and cracking down on stealing and reducing materials, illegal addition, adulteration, purchase of unqualified raw and auxiliary materials, OEM sales and data fraud And other illegal activities; continue to maintain the remediation of multi-component biochemical drugs, Chinese herbal extracts, and rubber products On February 28, Anhui food and Drug Administration issued the supervision and inspection plan for drug and cosmetics production and special drugs in 2018 70 easily dyed and weight-added herbal pieces and their finished products, easy to cut corners, unqualified products and products with quality risk indicated by the national standard are listed as the key drug production supervision varieties in 2018 Liaoning Province In March, Liaoning food and Drug Administration issued the provincial level supervision and inspection plan of Liaoning food and Drug Administration in 2018 According to the plan, Liaoning will inspect 40 drug wholesale enterprises, 100 drug retail enterprises and clinics, 20 cosmetics business enterprises, 20 medical equipment manufacturing enterprises, 14 medical equipment business enterprises and 14 medical equipment business enterprises There are 14 units using medical instruments February 28, 2018 Hebei drug production supervision work conference was held in Shijiazhuang The meeting stressed that to actively promote the supervision of drug production in 2018, we need to focus on the "seven enhancements" to improve the regulatory capacity In addition, this year, Hebei plans to carry out nine special renovations, and further use new tools such as big data and the Internet to carry out special inspections on APIs, Chinese herbal pieces, multi-component biochemical preparations, Chinese herbal extracts, injections, vaccines and blood products, data reliability, processing and export of drugs, and trunk distribution of vaccine manufacturers On March 30, Jiangsu food and Drug Administration printed and distributed 2018 key points of drug production supervision and supervision and inspection plan It is planned to carry out 7 special inspections in 2018, including: Chinese medicine injection manufacturers, adjuvant vaccines containing aluminum, compound oral solutions containing codeine manufacturers and operators, export of EU class II APIs, CO production varieties with F0 > 8 and F0 < 8, multi-component biochemical preparation peripheral extraction workshop or outsourcing extraction enterprises, enterprises issued warning letters by certification and evaluation center of Provincial Bureau in 2017 From March 8 to 9 in Hunan Province, the "work conference on drug registration and production supervision" was held in Changsha It was pointed out at the meeting that under the new situation of canceling GMP certification, Hunan planned to organize five special inspections, including Chinese herbal pieces, chemical APIs, sterile drugs (injections), multi-component biochemical drugs, Chinese herbal extracts and rubber products On March 30, Jiangxi Province, "Jiangxi drug production supervision meeting 2018" was held in Nanchang At the meeting, it was stressed that Jiangxi's drug supervision should achieve "Five" changes this year: first, from ensuring the availability of drugs to whether they are good or not; second, from "nanny" supervision to guiding enterprises to "self-discipline" management; third, from post supervision to the whole process supervision; fourth, from manual supervision to intelligent supervision; fifth, from punishing enterprises to punishing Enterprises Change to relevant responsible person In January 2018, Ningxia food and Drug Administration issued the notice on the supervision and inspection plan for drug manufacturers in 2018 The notice stressed that it will focus on the inspection of injection and aseptic preparations, basic drug varieties winning the bid, traditional Chinese medicine preparations of precious and fine herbs, varieties with difficult production process control and large output, etc And focus on the inspection of material management, legitimacy of raw and auxiliary materials sources, product release management; production management, focus on whether the enterprise organizes production according to the production process approved by the drug regulatory authorities.