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Director Bi Jingquan: Create inspection team,Strict inspection、Strict punishment!
Release time: 2016-09-23 & nbsp & nbsp & nbsp Source: Anonymous
  & ldquo; 2016 The first China Pharmaceutical Supervision Science Conference & rdquo; September 20th to 21st,The theme of the conference is & ldquo; Drug supervision reform and innovation & rdquo;。Bi Jingquan, Director of the State Food and Drug Administration, attended the meeting and delivered a speech。
 
  Bi Jingquan emphasizes,Party Central、The State Council attaches great importance to drug supervision。Drugs are special products for treating diseases and saving people,Drug supervision must follow the objective laws of drug research and development and production,Must understand the law correctly、Use rules,Further reform and stake sports betting appinnovation,Constantly improve the scientific level of supervision,Effectively ensure the safety and physical health of the people。
 
  Bi Jingquan said,Over the past year,The State Food and Drug Administration according to the Party Central Committee、The overall requirements of the State Council Reform Drug Review Approval System,launched a series of reform measures: simplifying the approval procedures for clinical trials of new drugs,Implementing record management of clinical trials of generic drugs,Clear drug clinical trial data for self -examination,Accelerate the approval of urgently need drugs in the market,Concentration force solves the backlog of reducing drug review,At present, the number of backlogs has been reduced from the highest time to 12,000 pieces。
 
  Bi Jingquan pointed out,Ensuring safety and effectiveness is the core essential of drug science supervision。Drugs are special products for disease prevention and disease,It is necessary to have exact effect,Control safety risk,Make the treatment benefits greater than the risk of treatment。
 
  Strictly follow the basic requirements of various specifications as the supervision of drug science。Drug companies must strictly follow drug development、Production、Relevant specifications in various links such as circulation,Recording related data truthfully,Let the drug R & D and production return to science。To establish a professional chemical inspector team,Strict inspection、Strict punishment,Promote the formation of advocating stake online sports bettingscience、Respect science、Conscience to do medicine、A good atmosphere of abide by the law。
 
  Consistency evaluation of the quality and efficacy of generic drugs is an inevitable choice for drug science supervision。Imitation drugs must be replaced with the original research drugs clinically。Promoting the consistency evaluation of generic drugs is & ldquo; 135 & rdquo; the primary task of drug supervision during the period。
 
  The reform of the drug review and approval system is to promote drug supervision more scientific。To speed up the pace of reform of drug review,Reconstruction of the drug technology review system。To highlight clinical lead,Implementation of the project administrator system,Establish a conference communication system for the review team and the applicant,Establishing an expert consulting committee system,Establishing review and approval information disclosure system。Establish and improve through system,Further promote the science of drug supervision。
 
  Enhancing service awareness is an important manifestation of drug science supervision。Enterprise is both the supervisory object of the regulatory authorities,It is also a service object。Drug supervision must guide the specifications first、Communication in China、Approval decisions are later,Regulatory supervision in service。
 
  This meeting was sponsored by the China Drug Administration Research Association。On the way,Shao Mingli, the president of the China Drug Administration Research Association, to the nearly thousands of & ldquo; stake betting appPharmacist & rdquo;、Production、Sales、Use、Evaluation、Personnel related to supervision related work,In protecting public health、In the cause of the safety and effectiveness of medication,Must bear economic responsibility、Legal liability、Social Responsibility、Political responsibility。& ldquo; Pharmacist & rdquo; We must effectively protect the legitimate rights and interests of producers,Create an orderly and orderly social environment; master the most advanced、The forefront、The most practical scientific knowledge、Technical means,Construct a scientific supervision system。
 
  Food and drug supervision departments from some provinces and cities、Technical support department,Academicians in the field of pharmaceuticals at home and abroad、Expert、Scholar、Entrepreneurs,Around the current series of drug supervision reform measures and difficult points facing pharmaceutical innovation development、hot issues interpreted and discussed。
 
  The meeting will play the role of drug supervision & ldquo; think tank & rdquo;,Create a duration of & ldquo;、Influence、High -level academic exchanges and cooperation platforms of vitality & rdquo;。
 
  Except for the main forum,The conference also has a drug quality supervision and drug safety and effectiveness、Interpretation of Pharmaceutical Accessories and Pharmaceutical Policies and Regulations、Scientific supervision of medical device、Research on the History of Drug Supervision and Development of Drug Standards、Food stake online sports bettingand Drug Supervision Culture and Industry Development、Institutional reform background, drug supervision capacity improvement research、Seven sub -forums of biological product supervision policies and industrial development。