August 26，National Health and Family Planning Commission、The official website of the State Drug Administration announced the inspection and rectification situation。

 

  10 key points of the National Health and Family Planning Commission

 

  According to the unified deployment of the central government，March 1st to April 30, 2016，The 15th Inspection Team of the Central Committee conducted a special inspection on the Party Group of the National Health and Family Planning Commission。August 26，The National Health and Family Planning Commission will announce the inspection and rectification.，Below is sorted out by Saibailan，and medical reform、Ten work priorities related to medicine:

 

  1，Each member of the National Health and Family Planning Commission is responsible for contacting the medical reform supervision work of 4-5 provinces。The party secretary takes the lead，Each member of the party group regularly contact the province，On the front line of medical reform, conduct research，Guide to promote the key work of medical reform;

 

  2，Strengthen & ldquo; Three Medical Links & RDQUO;，Carefully summarize and deepen the successful typical practice case of the reform of the pharmaceutical and health system.，Promoting mature experience，Promoting breakthroughs in medical reforms in various places;

 

  3，Focusing on the establishment of a hierarchical diagnosis and treatment system，Optimized medical and health resource allocation，Improve the policy system，It is intended to carry out hierarchical diagnosis and treatment pilots in 4 municipalities and 266 prefecture -level cities;

 

  4，Hold a meeting of comprehensive reform of urban public hospitals，Training for Stake Sports Bettingthe responsible comrades of 100 new public hospital reform pilot cities，Promote the establishment of a modern hospital management system，Accelerate the comprehensive reform of public hospitals;

 

  5, further improve the policy measures of the strong base layer;

 

  6，Deepen the reform of medical insurance payment methods，Vigorously implement the head of the person、Press the disease、Pay daily according to bed;

 

  7，Conjugated to the "Notice on Doing a Good Affairs of the New Rural Cooperation Medical Work in 2016"，Fully pushed the work of major illness insurance;

 

  8，Further improve the drug supply guarantee system，Printed "Notice on Doing a Good Affairs of National Negotiation Drugs"，Reduce drug virtual high price，Reduce the burden of medication for the masses;

 

  9，Printed "Notice on Determining the Growth of Medical Expenses as soon as possible"，Further control the unreasonable growth of medical expenses of public hospitals;

 

  10，In -depth management of commercial bribery in the field of pharmaceutical purchase and sales。Print "The Key Points of the Endless Wind in the Purchase of Medical Purchase and Medical Services in 2016"，Requires to implement it well。Printing "Notes on the Typical Questions of Unchanged Winds in Medical Purchasing and Sale and Medical Services"，Notice negative typical，Strengthen warning education。Implement "Opinions on Strengthening the Work of Commercial and Preventing Commercial and Advantaging Works of the Health and Family Planning System"，Improve the work institution，Strengthen and prosecution、Communication and coordination of public security organs，seriously investigating the violation of & ldquo; Nine inaccurate & rdquo;、Disgusters in medical purchase and sales and medical services。

 

  CFDA to do 24 things

 

  March 1st to April 30, 2016，The 15th Inspection Team of the Central Committee conducted a inspection of the Party Group of the State Food and Drug Administration (hereinafter referred to as the party group)，and feedback the inspection opinion to the party group。immediately，Party Secretary、Director Bi Jingquan hosted a party group meeting，Comprehensive deployment of rectification and implementation，So there is this rectification notice。

 

  In the "Notes"，The scope of rectification involves medicines、Equipment、Food。Consistency evaluation of generic drugs、Drug adverse reaction monitoring、Strengthening pharmaceutical companies' flying inspection、Special governance pharmaceutical companies are good at changing production technology、Safety re -evaluation of traditional Chinese stake betting appmedicine injection、Drug registration approval、Review、Drug production & ldquo; cut corners & rdquo;、 Drug clinical trial data fake、Rectification & ldquo; Qian Ying Qun Ticket & RDQUO; and so on。In short，As long as it is within the scope of the supervision of the General Administration，One of all links cannot be less。At the same time，Many strict rectification requirements are also proposed to the internal。

 

  Read the full text of the "Notice"，Obviously I can feel，After being inspected by the central government，The director personally hangs the handsome、Implementing & ldquo; Four the most stringent & rdquo; Requirements、It is necessary to comprehensively rectify the industry。

 

  Some of them may have a significant impact on the industry。The following is the key task related to the medicine related to medicine:

 

  1， Key rectification & ldquo;，Strengthen the regulatory in the field of drug circulation。Personal for & rdquo;，Medicine and illegal income from illegal operations，Feming fines; situations for operating amounts exceeded 100,000 yuan, etc.，Suspected of constituting a crime，Urges the local government to transfer the public security organs in accordance with the law to investigate criminal responsibility;

 

  2， Research proposes several opinions on improving the policy of drug production and circulation。According to the instructions of the State Council leaders，Organizational departments have drafted some opinions on the improvement of drug production circulation and use policies，In late June, it has been reported to the leaders of the State Council;

 

  3，Conjugated by the Development and Reform Commission and other relevant ministries and commissions issued the "Common Disciplinary Remint Records of Food and Drugs"，Develop "Regulations on the Management Regulations on Disciplinary Management of severe dishonesty and drugs"，Promote & ldquo;，Minding everywhere & rdquo;;;

 

  4，Policy -oriented in combination with deepening the reform of the drug circulation system，Hierarchical classification management of existing pharmaceutical wholesale enterprises;

 

  5，Investigation of Hubei and other provinces that conducted the pilot management pilot of the medical representative online in advance，Promote to various places in time;

 

  6，Hurry to revise the "Drug Management Law of the People's Republic of China"，Report to the State Council for review as soon as possible;

 

  7，Study the hierarchical management system of retail pharmacy，Formulate the corresponding management measures;

 

  8，Improve the safety re -evaluation work plan stake betting appof Chinese medicine injection，Organize the safety re -evaluation of traditional Chinese medicine injection;

 

  9，Keeping the Ministry of Public Security、The Supreme People's Procuratorate establishes a system of execution connection joint meeting，Adhere to regular consultation、Communication cooperation，Increase the punishment of illegal crimes;

 

  10，Strict implementation of the "Measures for Supervision of major food and drug safety violations"，Listed supervision of major food and drug violation cases;

 

  11，The Ministry of Public Security studies the establishment of product control、Case information release and other working mechanisms;

 

  12，Actively promote the construction of a national food and drug inspector team，Directly investigated some major inter -provincial cases;

 

  13，Amend the "Principles of the On -site Inspection and Guidance of Drug Management Quality Management Standards";

 

  14，& ldquo; hidden rules & rdquo; Question，It is organizing research related inspection methods;

 

  15，Continue to supervise and guide the implementation of the implementation rules of food and drug administrative law enforcement and criminal judicial connection work methods; in conjunction with the Ministry of Public Security、The Supreme People's Procuratorate establishes a system of execution connection joint meeting，Adhere to regular consultation、Communication cooperation，Increase the punishment of illegal crimes;

 

  16，Promote the company's consistency evaluation of chemical generic drug oral solid agents in the national basic drug catalog approved by October 1, 2007;

 

  17，Formulate the "Standards for Strengthening the Disposal of Phantom Early Signal Early Warning" "Principles of Disasement of Drugs and Disposity of Drug Inspection";

 

  18，Special governance drug manufacturers change process problems without authorization;

 

  19，Resolutely rectify the production order of drugs，Strengthening the flight inspection of pharmaceutical manufacturers，Investigation and punishment of violations of laws and regulations;

 

  20，Fighting the backlog of the drug registration application before the end of the year;

 

  21，The revised draft of the "Administrative Measures for the Registration of Drugs" has been completed，Next，Continue to improve the "Administrative Measures for Drug Registration"，Published implementation as soon as possible;

 

  22，Resolutely rectify the clinical trial data of drugs。Strive to complete all the drug clinical trial data verification before the end of June 2017; revise the "Specifications for Quality Management of Clinical Test of Drugs";

 

  23，Strengthen the supervision and inspection and sampling inspection of food and drug production and operation enterprises，Checking clinical trial data of strict drug declaration data;

 

  My stake betting app24，Carrying out drug business enterprises to cancel vaccine business qualifications related。Track supervision of the “Drug Operation Licensing Certificate" and the work scope of the operating enterprise of the vaccine operation of various provincial food and drug supervision departments，Make sure to complete before January 31, 2017;

 

  According to the "Notes" display，The content of this inspection and rectification was formulated in June，Some rectification projects such as: increase the force of the flight inspection、Governing pharmaceutical companies good at changing production technology、Circulation inspection, etc.，All have been launched and strictly executed。and some more revolutionary measures for the industry, such as: pharmaceutical filing、Revised Drug Management Law、Grade management of drug wholesale enterprises、Safe re -review of traditional Chinese medicine injection, although there is no surface，But it's just a matter of time。