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Provincial Food and Drug Administration: Promoting the high quality development of the pharmaceutical industry

Provincial Food and Drug Administration: Promoting the high quality development of the pharmaceutical industry

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[Abstract]:
AtthebeginningoftheestablishmentoftheProvincialDrugAdministration,itcoincidedwiththedeploymentoftheprovincialpartycommitteetocarryouttheemancipationofthemindtopromotethehigh-qualitydevelopmentofJilin.Theprovincialbureaucombinedwiththeactualsituation,thinkingwithproblems,discussingwithproblems,solvingproblemswithproblems,andworkinghardtosolvecontradictionsandsupplements.Shortboard,turntostyle,improveefficiency,ensuresafety,andpromotedevelopment. "Inthebigdiscussionactivities,weinsistedonputtingtheemancipationofthemindtoboostdevelopmentconfidence,evokethespiritofattackinghardshipsandappointingentrepreneurs;andembodytheresultsoftheupdatedconceptinsafeguardingthesafetyofthepeople'smedicationandpromotingmedicine.Thespecificmeasuresandmethodsforthehigh-qualitydevelopmentoftheindustry."Duringtheconversation,LiuBaofang,thedirectoroftheProvincialFoodandDrugAdministration,wasfirm. Accordingtoreports,thisinstitutionalreform,thefunctionoftheprovincialdrugregulatorydepartmenthasundergonegreatchanges,mainlyresponsibleforlicensing,inspectionandpunishmentofpharmaceutical,medicaldeviceandcosmeticproductionlinks,aswellasdrugwholesalelicense,retailchainheadquarterslicense,Internetsales.Third-partyplatformfiling,inspectionandpunishment,moreprofessionalandtechnicalrequirements. AsoftheendofOctober,theprovincehadatotalof367pharmaceuticalmanufacturers(includingmedicalinstitutions),704pharmaceuticalwholesalecompaniesandretailchainheadquarters,290medicaldevicemanufacturers,40cosmeticsmanufacturers,and13690drugapprovals.Itaccountsfor8.2%ofthecountry.Adheretothegoalorientationandproblemorientation,adapttothenewera,newsystem,newfunctions,focusonthestandard,resolveconflicts,furthersolvethedrugsafetyconcernsofthepeople,andpromotethehigh-qualitydevelopmentofthepharmaceuticalindustrythroughprofessionalservices.TheProvincialFoodandDrugAdministrationhasstudiedandresolvedthekeypointsinthebigdiscussion. Intermsofstrongsupervision,theProvincialFoodandDrugAdministrationhasimplementedscientificsupervision,targetedsupervision,andeffectivesupervision,andactivelyintroducedmarketregulationmechanismstocomplementthegovernmentandthemarket's“twohands”.Specifically,theProvincialFoodandDrugAdministrationwillspeeduptheimprovementofthevaccinedrugregulatorysystem,theconstructionofprofessionalinspectors,reportingrewards,drugqualityriskassessment,qualityinspectionandtesting,strengtheninglogisticsandtransportationsecurity,productrecall,increasingpenaltiesforviolations,andstrengthening9long-termmechanismssuchasvocationalskillstraining,strictpreventionofriskhazards,strengtheningsupervisionintheworkplace,strictpost-punishment,strengtheningtechnicalsupport,preparingthe"InspectionOperationManual",leveragingthe"DigitalJilin"construction,planninganddesigningdrugs"digitalsupervision",Furtherstrengthenthedrugsafetysupervisionwork,realizetheclosed-loopsupervisionoftheentireprocess,thefullcontroloftheresponsibility,andthefullimplementationofsupervision. Strongsupervisionisalsopromotingdevelopment.LiuBaofangsaid,"Thedrugsupervisiondepartmentwillhighlightthemainresponsibility,rationalizeregulatorymatters,openup'capillarybloodvessels',removetheblindspotsofsupervision,conscientiouslyimplementthe'fourmoststringent'requirements,andregulatetheproductionandoperationorderofmedicines,medicaldevicesandcosmetics.Inaccordancewiththelaw,severelypunishviolationsoflawsandregulations,andfullyprotectthesafetyofpublicuseofdrugs." Intermsofpromotingdevelopment,theProvincialFoodandDrugAdministrationwillconscientiouslyimplementthedeploymentandrequirementsoftheprovincialpartycommitteeandtheprovincialgovernment,activelybuilda"pro-"and"clear"political-businessrelationship,furtherimproveserviceefficiency,andactivelypromotethe"distributionservice"and"onlyrunonce"reform.Continuetopromotethereformofthedrugandmedicaldevicereviewandapprovalsystem,increasethesupportforenterprisesthatpasstheevaluationofthequalityandefficacyofgenericdrugs,andpromotetheimplementationofthedruglistingpermitholdersysteminourprovince;guideenterprisestoincreaseR&DinvestmentandimproveIndependentinnovationabilityandleveltoenhancecorecompetitiveness.Activelycarryoutthe"consultation"serviceofthegrassrootsandenterprises,strivetobringthepolicytothedoor,puttheserviceinplace,activelycreateasoftenvironmentconducivetothedevelopmentoftheenterprise,promotethecompanyoutofnothing,andpromotetheproductstohaveanewlife.
At the beginning of the establishment of the Provincial Drug Administration, it coincided with the deployment of the provincial party committee to carry out the emancipation of the mind to promote the high-quality development of Jilin. The provincial bureau combined with the actual situation, thinking with problems, discussing with problems, solving problems with problems, and working hard to solve contradictions and supplements. Short board, turn to style, improve efficiency, ensure safety, and promote development.
 
"In the big discussion activities, we insisted on putting the emancipation of the mind to boost development confidence, evoke the spirit of attacking hardships and appointing entrepreneurs; and embody the results of the updated concept in safeguarding the safety of the people's medication and promoting medicine. The specific measures and methods for the high-quality development of the industry." During the conversation, Liu Baofang, the director of the Provincial Food and Drug Administration, was firm.
 
According to reports, this institutional reform, the function of the provincial drug regulatory department has undergone great changes, mainly responsible for licensing, inspection and punishment of pharmaceutical, medical device and cosmetic production links, as well as drug wholesale license, retail chain headquarters license, Internet sales. Third-party platform filing, inspection and punishment, more professional and technical requirements.
 
As of the end of October, the province had a total of 367 pharmaceutical manufacturers (including medical institutions), 704 pharmaceutical wholesale companies and retail chain headquarters, 290 medical device manufacturers, 40 cosmetics manufacturers, and 13690 drug approvals. It accounts for 8.2% of the country. Adhere to the goal orientation and problem orientation, adapt to the new era, new system, new functions, focus on the standard, resolve conflicts, further solve the drug safety concerns of the people, and promote the high-quality development of the pharmaceutical industry through professional services. The Provincial Food and Drug Administration has studied and resolved the key points in the big discussion.
 
In terms of strong supervision, the Provincial Food and Drug Administration has implemented scientific supervision, targeted supervision, and effective supervision, and actively introduced market regulation mechanisms to complement the government and the market's “two hands”. Specifically, the Provincial Food and Drug Administration will speed up the improvement of the vaccine drug regulatory system, the construction of professional inspectors, reporting rewards, drug quality risk assessment, quality inspection and testing, strengthening logistics and transportation security, product recall, increasing penalties for violations, and strengthening 9 long-term mechanisms such as vocational skills training, strict prevention of risk hazards, strengthening supervision in the workplace, strict post-punishment, strengthening technical support, preparing the "Inspection Operation Manual", leveraging the "Digital Jilin" construction, planning and designing drugs "digital supervision", Further strengthen the drug safety supervision work, realize the closed-loop supervision of the entire process, the full control of the responsibility, and the full implementation of supervision.
 
Strong supervision is also promoting development. Liu Baofang said, "The drug supervision department will highlight the main responsibility, rationalize regulatory matters, open up 'capillary blood vessels', remove the blind spots of supervision, conscientiously implement the 'four most stringent' requirements, and regulate the production and operation order of medicines, medical devices and cosmetics. In accordance with the law, severely punish violations of laws and regulations, and fully protect the safety of public use of drugs."
 
In terms of promoting development, the Provincial Food and Drug Administration will conscientiously implement the deployment and requirements of the provincial party committee and the provincial government, actively build a "pro-" and "clear" political-business relationship, further improve service efficiency, and actively promote the "distribution service" and "only run once" reform. Continue to promote the reform of the drug and medical device review and approval system, increase the support for enterprises that pass the evaluation of the quality and efficacy of generic drugs, and promote the implementation of the drug listing permit holder system in our province; guide enterprises to increase R&D investment and improve Independent innovation ability and level to enhance core competitiveness. Actively carry out the "consultation" service of the grassroots and enterprises, strive to bring the policy to the door, put the service in place, actively create a soft environment conducive to the development of the enterprise, promote the company out of nothing, and promote the products to have a new life.