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The General Administration of Drug Administration: The revision of the Drug Management Law enters the critical stage
Release time: 2016-11-25 & nbsp & nbsp & nbsp Source: Anonymous
   & ldquo; "Drug Management Law" since it was promulgated and implemented in 1984,Starts that have gone through more than 30 years,The revised distance in 2001 has more than 10 years,With the continuous development of socio -economic,This method can no longer fully adapt to supervision needs in the new situation。& rdquo; Xu Jinghe, the director of the State Administration of Food and Drug Administration (hereinafter referred to as CFDA), said at the 28th National Medical Economic Information Conference: & ldquo;,The revision of the "Drug Management Law" has entered a critical stage,We hope to solicit opinions from the society as soon as possible。& rdquo;
 
  Encouraging innovation is the biggest highlight
 
  Speaking of the revision and progress of this "Drug Management Law",Xu Jinghe said: & ldquo; Stake Sports BettingThe stake betting appindustry is very concerned about encouragement and innovation issues,my country's "Drug Management Law" at the beginning of formulation,Existing & lsquo; phenomenon of heavy production and development & rsquo;,Affected by the development stage and the restraint of the planned economic concept,Inconsistent incentives to R & D and innovation,So,During the revision of the Drug Management Law,We will take more measures to encourage innovation。& rdquo;
 
  According to reporters,,Pharmaceutical companies are very concerned about the priority review system、Data protection system、Patent Link System、Patent extension system、New drug monitoring system、Market exclusive system, etc.。
 
  For the drug listing license system (hereinafter referred to as MAH),How does the prospects of its pilot are also many pharmaceutical companies、Focus on the attention of the R & D institution。
 
  Xu Jinghe admits: & ldquo; We analyzed and compared some measures at home and abroad,I hope to fully learn from the MAH system that encourages drug innovation in My stake betting appthe international community,I hope to implement the pilot of MAH,Make society more understanding the function of this system。MAH system can not only encourage drug innovation,You can also optimize resource allocation,Implement corporate responsibility,Promoting supervision innovation。& rdquo;
 
  Drug approval documents for pharmaceutical companies to be eager to expect,Xu Jinghe admits: & ldquo; This problem is very concerned about the industry,Pay attention to it during the revision。Drug approval documents have property attributes,At the same time, it has certain administrative attributes,The new method stake online sports bettingneeds stake online sports bettingto give clear positioning。As a property attribute,It should be transferred; with administrative attributes,Transfer permits need to perform administrative procedures,Is the filing system,Still approval system,You need to explore further。Acknowledged is,The change of the holder can further stimulate the vitality of my country's pharmaceutical market。& rdquo;
 
  How to express the final finalization of the "Drug Management Law",Xu Jinghe did not disclose,He encouraged the participating representatives here: & ldquo; For encouragement innovation,New "Drug Management Law" will guide the Chinese pharmaceutical industry from imitation to innovation,By further improving the market mechanism,Implementing transfer and letting go、Transfer let go、Commission to let go,Fully release reform dividends。& rdquo;
 
  Strengthen the responsibility of the company's main body
 
  In terms of corporate supervision,Pharmaceutical companies also expect: The new law can reform the supervision method,Reduce the burden on the enterprise,Under the generous needle of the agent and decentralization,Realize efficient supervision。
 
  Xu Jinghe admits: & ldquo; The current "Drug Management Law" is responsible for the main body of the enterprise,Regulations to compare principles。Amendment,We will further strengthen the main responsibility of the enterprise as the first responsible person,It will further refine the main responsibility of the enterprise around risk management and quality control。& rdquo;
 
  Under the generous needle of the agent and decentralization,New Fa will cancel GLP、GSP、GMP、GCP certification。Xu Jinghe emphasized: & ldquo; From the perspective My stake betting appof My stake betting appthe international community,Drug supervision is mostly through 3 development stages。The first stage is mainly qualification management,It mainly focuses on administrative license; the second stage is mainly system management,Mainly paying attention to process control; the third stage is mainly capacity management,Mainly pay attention to the management ability of the enterprise。The revision of the "Drug Management Law" must be conducive to comprehensive prevention and control of risks、Comprehensive implementation of responsibility、The comprehensive advancement of the system and the comprehensive improvement of capabilities。& rdquo;
 
  Pay close attention to pharmaceutical e -commerce
 
  Since last year,Medical e -commerce has attracted much attention,Especially the lifting of the ban on the sale of prescription drug network,Has been highly expected by the industry,And the OTC of the Tmall Medical Museum OTC,It also makes the industry worry about the prospects of pharmaceutical e -commerce。
 
  For pharmaceutical e -commerce,Xu Jinghe revealed: & ldquo; During the revision of the Drug Management Law,I also pay much attention to the rapid development of pharmaceutical e -commerce,These years,The development of the Internet economy is fast,Especially drug transactions,Make me have some new thinking,The industry also feedback a lot of opinions,In the new law,We are willing to listen to different opinions。& rdquo;
 
   & ldquo; Two votes & rdquo; It is also a topic that the representatives of the conference attended the meeting。Xu Jinghe said: & ldquo;,I also have a new understanding,During the process of drug circulation,What kind of legal relationship between distribution and My stake betting appstake betting appdistribution,It caused me to think。Delivery and distribution are completely different formats,Delivery provides only transportation services,Earn labor costs; and distribution is direct distribution drugs。With the implementation of the two votes & rsquo;,Drug circulation methods will change some changes,Repairing method will also be followed。& rdquo;