The Drug Regulatory Mechanism Research Based On The Full Life Circle Management Of Drug

BackgroundMedicine is a special commodity which quality and safety concerns life safety and health of everyone.Our country has built the basic tend to be more standard and perfect drug management system at present.which mainly including the administrative supervision system from national,provincial,city to county level.and the technical support system emphasis on the drug registration.review standards,testing technical support system and the adverse reaction monitoring.At the same time a series of policy measures,set up covering a important regulatory system including circulation use drug research and development production.In March 2013,the country implements three innings system reform improve the level of the food and drug supervision and administration,to exercise unified supervision over the food and drug administration.While increasing the drug safety supervision in our country.ln recent years our country drug adverse events emerge in endlessly,reflects the drug regulation is still a problem in our country,solving the issue of drug safety is urgent.In order to solve the increasingly serious drug safety,this paper puts forward to the full life cycle management of drugs.The full life cycle management drug is to build a unified platform,taking charge of the drug fiom procurement of raw materials、Chinese herbal medicine planting to the production flow and the use of the whole tube after listed,timely discover and solve the problem of drug safety.ObjectiveIn this article,through analyzing the state of drug safety regulation in China and the regulation of foreign drug electronic system,according to the requirement of full life cycle management,analysis the drug safety regulation,existing problems and reasons in our country,the author puts forward some Suggestions on the whole life circle management in China.MethodsThrough literature review and policy analysis,study the practice of safety supervision of some countries,the changes in drug safety regulatory policy,analyze the suggest which can perfect the policy in China.Through the investigation in Jungian,Shijiazhuang,Huber,Sicilian,Jilin,and Ginsu province,using the method of key figures interviews and focus Group Interview,analysis the present condition of the whole life circle of drug management in China and the existing problems.,at the same time.ivestigating the possible causes.ResultsThe study found that the life circle management of drug in our country mainly exist the following problems:1.Problems existed in drug regulatory system in our country.Under the current vertical leadership system.the central power often will affect the right use of local regulator,arise the phenomenon of disconnect or mufti-layer supervision.affect the authority and effectiveness of drug safety regulation.2.The quantity and quality of drug safety supervision cannot meet the needs of the drug safety supervision work.3.There are loopholes exist in the transportation and storage of drugs in our country,relevant laws and regulations has not stipulated standards and social logistics drug transporting and storing or Courier for the responsibility of the transport of drugs,medicines may appear squeezed and be affected with damp in transit..Many drug retail terminal especially individual clinic drug store and rural clinic cannot be guaranteed.4.The aspect of prescription drugs belled in Retail pharmacies.Prescription sources and be equipped with licensed pharmacists is a regulatory focus and difficult problem in the field of drug circulation.The country has no explore effective solutions.At the same time,the Internet sales of prescription drugs are still exist many problems.Conclusions and SuggestionsThere have a gap on the regulatory system、the Chinese medicine and raw materials、the production process、the circulation and the sector of using between the present drug management and the requirements of whole life circle of drug safety management.Based on the problem of drug safety regulation in our country,put forward the following suggestions:1.Establish the drug tracking management system which based on the whole life circle of drug management,build a information platform on the unified national drug safety,tracking and managing every aspect of drug life circle from the source to retail terminals,timely discover and solve the problem of drug safety.2.To improve the oversight system for drug,set a single supervisory role and a single regulator,avoid repeat and blank of drug management.3.To extend drug regulatory chain and formulate a policy to strengthen supervision over the use and procurement of raw materials,put retail terminals,such as medical institutions,schools,and rural clinics in supervision,to improve the overall life circle management of medicines.4.Strengthening the monitoring of drug safety personnel,as well as to the whole life circle of drug system regulation.5.Carry out the system of grading management for drug retailers,Strengthen the supervision of prescription drug sales.