Research Administrative Approval System Imported Drugs

Administrative approval is one of the great practice of reform and legalconstruction. Administrative examination and approval system is widely present in allareas of administrative enforcement. Closely related to the administrative examinationand approval of imported drugs in the vital interests of the professional field, theestablishment and implementation of administrative examination and approval systemwith the masses. First is that imported drugs on the development of China’spharmaceutical industry has played a pivotal role. Lacking in a lot of imported drugsfor rare diseases, cancer, etc. China is currently difficult to produce medicines, thesedrugs on our patient’s medication therapy and improve the vitality of China’spharmaceutical market, increasing drug market have a vital role; secondly that, I carefor rare diseases by participating in activities found that currently exist in the field ofimported drugs biggest problem is a lot of drugs difficult to enter into the Chinesemarket, causing difficulties in patients with medication, the main cause of thisproblem is that the existing system of administrative examination and approval ofimported drugs are not adapt to rapid social and economic development of our country.For these reasons in the context of the reform of administrative examination andapproval, I hope to pass legislation to regulate the import of existing drugs, and comparative analysis of the administrative examination and approval system offoreign pharmaceutical imports, imports of pharmaceuticals identify possibleadministrative examination and approval system suitable for China.In this paper, the introduction of drugs imported from China in recent years toapply for registration, re-registration application for approval of a supplementalapplication data to start, the relationship between the imbalance imported annuallyinto the Chinese market demand for drugs and medication in patients withcomparative analysis. Imported drugs gradually in-depth study of existingadministrative examination and approval system based on this lead. In addition to theintroduction of this article as well as chapters.Chapter1: Administrative Examination and Approval System analysis of importeddrugs. Faced with the applicable legislation in the field of imported drugs complicatedcase, the chapter from the legal department and then to the administrative rules andregulations, Analysis and drill down method of analysis to identify the existing patternof administrative examination and approval of imported drugs. When comparingdifferent legislative conflicts arising out of administrative examination and approvalof imported drugs to identify existing problems in these conflicts, simultaneousanalysis of institutions and mechanisms of administrative licensing of imported drugs,thereby grasp the analysis of drug approval system on imports from the global.Chapter2: Imported Drug Administration Approval System Problems andinfluence. This chapter first chapter of comparative analysis on the basis of legislativeprovisions to identify existing administrative examination and approval systemimported drugs problems and adverse effects of the existing system of administrativeexamination and approval of imported drugs and patients brought to the enterprise.The combination of issues and impacts, noting our existing system of administrativeexamination and approval of imported drugs must be reformed.Chapter3: The reason imported medicines administrative approval system defectanalysis. Explore in depth the issues, identify the cause of these problems arise.Starting from the legislation, the particularity of imported drugs, imported drugs andother administrative approval body depth analysis carried cause analysis. Chapter4: improving the administrative examination and approval systemimported drugs. Through the first three chapters of foreshadowing, then comparativeanalysis of administrative examination and approval system drugs imported UnitedStates, European Union, Canada and other countries, combined with our objectiveeconomic situation of our country to find a suitable system of administrativeexamination and approval of imported drugs. The system from the classification ofdrugs, the procedures, different suggestions on improving risk control, hoping toreform China’s current system of administrative examination and approval ofimported drugs made viable option.In this paper, a large number of Chinese paper-based reading and DrugAdministration Approval System Reform of administrative examination and approvalsystem, combined with related drugs legislation, the use of normative analysis,comparative analysis. China’s imports of pharmaceuticals for the administrativeexamination and approval system to conduct a comprehensive and systematic analysisto explore.