recently,Liaoning food and Drug Administrationconvene2018Provincial Conference on drug and cosmetic supervision in,Deploy the key supervision tasks of drugs and cosmetics in the year.2018year,The supervision of drugs and cosmetics in the province will adhere to make progress while maintaining stability General tone of work,Fully implement the main responsibility of enterprises,Adhere to the concept of risk management,Focus on eight aspects.

oneIt is to continue to increase the rectification of key links and prominent problems.First, we should continue to maintain the control of multi-component biochemical drugs Traditional Chinese medicine extract Rubber products Drug wholesale link Regulation of small pharmacies and clinics in the fringe of urban and rural areas,Consolidate the achievements of special rectification,Strictly prevent the resurgence of illegal acts.Second, we should focus on the supply chain of raw and auxiliary materials Special inspection and centralized rectification of problems such as decoction pieces of traditional Chinese Medicine,Focus on investigating and cracking down on Jerry built work and materials Illegal addition Doping makes false Production not according to process Illegal acts with hidden rules such as purchasing unqualified raw and auxiliary materials, OEM sales and data fraud.Third, carry out special inspection of injections,Focus on the source of raw materials or medicinal materials Process stability Control of key links Sterility assurance level Inter batch differences, etc,Enterprises with problems shall be dealt with seriously.Fourth, we should strengthen the inspection of data reliability,For non traceability of data untrue,Malicious fabrication of records file,Delete Data selection and other issues,Constantly standardize drug production behavior.Fifth, enterprises and regions where unqualified cosmetics are found to be concentrated in sampling inspection,Strengthen flight inspection,We will further crack down on illegal additions and counterfeits.Sixth, we should organize and carry out comprehensive rectification of cosmetics business links,Strengthen the supervision of online sales of cosmetics,Supervise the cosmetics business enterprises to implement the certificate and ticket system.

twoIs to speed up the pace of drug regulatory innovation.Reform the concept and method of inspection,When checking the overall quality system and quality assurance level of the enterprise,To explore risk tips Warning letter Four layered disposal measures of filing a case for investigation and transfer to the judicial organ.

threeIs the overall use of inspection test Monitoring and other means,Improve risk identification Prevention and disposal capacity.Unqualified products found in sampling inspection,Go back to the source,Carry out upstream and downstream extension inspection,Find the cause of the problem.Risks and hidden dangers found in exploratory research in sampling inspection of national evaluation,Carry out risk research and judgment consultation,Effectively control the extent and scope of risks.Carry out data analysis on various sampling inspection information,Mining possible regional and systemic risks.The aggregated adverse reaction signals found shall be studied and judged at the first time inspect test management,And urge enterprises to take the initiative to check Thorough rectification.

fourIs to do a good job in the implementation of the new laws and regulations.Firmly grasp the revision Drug Administration Law as well as Measures for the administration of drug inspection Measures for drug data management Measures for the supervision and administration of online drug trading Measures for the administration of drug marketing license holders Standard for quality management of traditional Chinese medicine production And other five departmental regulations,Implement the new ideas formed in drug supervision and reform New ideas new measures,Further implement the main responsibility of enterprises.

fiveIt is to strengthen the supervision and inspection of adverse reactions directly reported by production enterprises.Strengthen the inspection on the implementation of the system of direct reporting of adverse reactions by production enterprises,Severely investigate and punish enterprises that fail to fulfill their direct reporting responsibilities No pharmacovigilance system has been established Failure to formulate pharmacovigilance system and other behaviors.

sixWe attach great importance to vaccines Supervision of blood products and special drugs.Develop vaccine,Especially aluminum adjuvant vaccine,And full coverage special inspection of blood product manufacturers According to the specified frequency,For narcotic drugs The designated production and trading enterprises of psychotropic drugs and pharmaceutical precursor chemicals and the enterprises producing compound preparations with special drugs shall carry out supervision and inspection Develop the second category of psychotropic drugs based on codeine compound oral liquid preparations,And vaccines Special treatment of circulation links of blood products.

sevenIt is to promote information disclosure and social co governance.Public inspection test Monitoring situation,Increase the public exposure of problems found.Supervise enterprises to carry out information disclosure,Take the initiative to explain the problems found to the public Explain the reason,Improve enterprise information transparency,Increase public and social participation.Focus on media communication,Scientific application of the law of information dissemination in the era of new media,Attach importance to public opinion disposal and response,Make your voice heard early Early disclosure Early disposal.

eightFirst, strengthen team building,Improve regulatory capacity.Improve the assessment and employment of drug inspectors Training improvement Elimination and withdrawal system,Promote the construction of professional inspectors.Innovative training mechanism,Enhance the pertinence and systematicness of training,Improve the inspector's ability to check and handle cases and fix evidence,Build a team with excellent style A team of highly skilled inspectors.