Issue And Improvement Of Administrative Examination And Approval Procedures For Imported Drugs

In the summer holiday of 2018,the small-budget movie "I am not the god of medicine" was popular in all cinemas across the country,and the circle of friends was tear-eyed refresh.It tells the story of a patient with "CML" who had to "fight" authorities by smuggling generic drugs from India because imported drugs were too expensive.Internet users jokingly called "can’t afford to live in a house,can’t afford to go to school,can’t afford to eat medicine has become the current pressure on our people’s three mountains." Advanced imported drugs are a lifesaver for the seriously ill.The current import drug examination and approval system adopts the "one body,two levels" system.In principle,the applicant should directly submit the application to the central food and drug supervision department,and under the circumstances of legal provisions,the local government should conduct formal examination and the central government should make the final approval.At the level of regulatory documents,the drug administration law and the regulations on the implementation of the drug administration law guide the whole drug approval system,and specific regulations are formulated in specific drug fields for adjustment,such as the drug import administration measures.China’s current import drug examination and approval system plays an important role in the safety monitoring of imported drugs.However,with the development of the society,its disadvantages begin to emerge,such as the confusion of normative documents,unreasonable institution setting,old management mode and so on.These include problems such as high drug prices and long lead times,as reflected in the film.As 18th-century statesman Edmund burke said,change is a means of self-preservation.In order to maintain the constancy of the standard,it is necessary to constantly improve the existing problems and achieve a kind of stability in the change,and the improvement of the program is an inevitable means to ensure that the change remains within a reasonable range.Therefore,to solve the above problems,specifically:On the basis of clarifying the relationship between administrative examination and approval and administrative licensing,the examination and approval of imported drugs must be incorporated into the regulations on procedural provisions of the administrative licensing law to improve the drug examination and approval procedures.First,introduce the principle of reasonable administration.In particular,in the aspect of taking a long time for clinical practice and testing,it is required that the administrative act must meet the legislative purpose of relevant laws and meet the reasonable expectation of the public,instead of only taking the compliance with legal provisions as the standard.Second,we will make more public the examination and approval of imported drugs.To ensure the rationality of import drug examination and approval,the participation of the society should be introduced,and the reasonable expectation of the general public should be incorporated into the whole process of examination and approval.Therefore,the hearing system and communication system should be specified to facilitate social supervision and reduce the possibility of using power for personal gain.Third,the laws and administrative regulations shall authorize a group of qualified industrial institutions to conduct examination and approval,so as to provide legal institutional guarantee for streamlining administration and delegating power.In line with the spirit of the central government’s administrative examination and approval reform,we will deepen the reform of the examination and approval system for imported drugs.Second,at the level of hierarchy within the system,the central vertical leadership should be strengthened to reduce the differences between different approval systems and strengthen the specialization of drug approval.Finally,at the later supervision level,the construction of special post-review procedures should be accelerated,so as to change the old system of emphasizing examination and approval over supervision,and to provide guarantee for reducing the heavy examination and approval items at the early stage.Based on the comprehensive analysis for examination and approval of imported drugs,on the basis of current laws and regulations,compared to outside similar domain management system and mechanism,combining with the reform of administrative examination and approval of all documentation requirements,especially the requirement and to delegate,from the guiding ideology to the specific measures,top-down,from macroscopic to microscopic comprehensive questions facing the improvement of the structure,so as to provide reference for reform in the field of current administrative examination and approval of drugs to be imported.