May 3，The State Administration of Food and Drug Administration issued the "Announcement on the Rectification of illegal Operations in the Field of Drugs"，Requires all drug wholesale companies to be suspected of whether there is any existence of existence、Tickets and other questions for self -check，Formulate rectification measures and plans。The announcement also requires all drug wholesale enterprises to submit a self -inspection report before May 31 to various provincial drug supervision departments。

 

  At present, the company's self -examination is over，According to the author, I learned，To actively respond to the requirements of the State Drug Administration，Ensable compliance management of the circulation of drugs，More than 30 provinces nationwide (municipality、Autonomous Region) have all sent and implemented special rectification work in the area of ​​their respective jurisdictions。So，How does the drug supervision and management department at all levels implement special rectification of drug management?

 

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  1. Formulate a plan。Each pharmaceutical regulatory department analyzes the phased compliance business situation、Pre -judgment，Tightly combined with compliance business characteristics，Stake Sports BettingStake Sports BettingPersevere problem -oriented，Clarify the task of special rectification、Fields and Regions，Regulatory departments coordinated coordination and forming a special rectification plan for the next month.。

 

  2. Formulate a plan。Each pharmaceutical regulatory department shall be based on the actual situation and risk prediction of the proposed special rectification objects，Establish a specific work plan，Determine the special rectification task、route、Object、Methods and key links，and do a good job of responding to emergencies，Implement preventive measures，Protect yourself safety。

 

  3. Organizational training。Before launching special rectification，Each drug supervision department organizes all inspectors for training，Familiar with the relevant policies、Laws and regulations and safety knowledge，Clear work requirements and task division of labor and precautions。

 

  4. On -site inspection。Give full play to the role of experts，Deeply conduct inspections，Putting the hidden dangers and problems found on the spot according to law，and fill in the inspection record carefully，Do a good job of obtaining evidence for illegal illegal drug business behavior。Pharmaceutical business units with major hidden dangers and illegal acts，Observation of production and rectification in accordance with the law，and instructed relevant local departments to impose law enforcement penalties in accordance with laws and regulations;,It will trace the supervision and enforcement of relevant local government departments; seriously endanger compliance operations、It may cause drug quality accidents at any time，Take care of business in accordance with the law、Escape from emergency response measures。Typical experience and good practices found in the inspection，Each drug supervision department will summarize it in time。

 

  5. Report feedback。After the special rectification is over，Each drug supervision department will timely report to the inspector and its local drug supervision and management department and related departments in time，Pointing out the problems found，Specifications for rectification treatment requirements and further strengthening work。

 

  6. Report for centralized stake betting appreport。Regulatory departments stake online sports bettingtrack the work conditions of various drug supervision departments，Arrange a centralized report to the provincial bureau or other related meetings。Special serious problems and hidden dangers，Each drug supervision department will immediately report to the leaders of the provincial bureau，According to the leadership instructions of the Provincial Bureau，A law enforcement instructions are issued according to law。

 

  7. Supervise the rectification。Each drug supervision department will establish a list of major hidden dangers and outstanding issues found，Send a rectification notice to the drug supervision and management department where the inspection unit is located and track the supervision。Hidden dangers and problems on key difficulties，It will be supervised by the listing，Timely interview the person in charge of the relevant units and relevant departments，Develop & ldquo; look back at & rdquo;;，You can ask local governments to severely punish them in accordance with the law until it is closed。The drug supervision department believes that it is necessary to be included in & ldquo; blacklist & rdquo; management，It will be included in the management system in time。

 

  8. Data archive。Each drug supervision department will improve the inspection and inspection work account，Do a good job of special rectification、Video and other information archive and save work。

 

  Remediation object

 

  Including but not limited to the field of medical circulation，That is the field of drug research and development、Field of drug production、Drug circulation field、Drug use areas may be possible。

 

  Remediation content

 

  Vaccine、Blood Products、Anesthesiologist、Psychiatric Drug Preparation、Containing special drugs compound preparations、refrigerated frozen medicine、Chinese medicinal materials、Chinese medicine drinks, etc. are key varieties，Key check the business scope of the drug business unit、Quality Management System、Practitioners、Facilities and equipment、Computer system、Receiving and acceptance、Transportation and storage, etc.，Strict investigation and punishment & ldquo;Stake Sports Betting、& ldquo; Ticket & rdquo;My stake betting app、Rental lending licenses and purchasing drugs from illegal channels and other illegal behaviors and other illegal behaviors，Strictly investigate the phenomenon of disadvantages of special drugs in the enterprise。At the same time，Increase the management of pharmacies in medical institutions，Key check the purchase of drugs for medical institutions、Storage、Preparation、Use compliance and adverse reaction reports。

 

  Remediation method

 

  1. Unannounced visits。Take field survey、Visit for an unannounced visit、Specific interview、Sample detection and other methods，Recording videos、Telephone consultation、Simulation services and other means。It is reported，Some unannounced inspectors will use business negotiation as the method，Communicate with the person in charge of the business of the enterprise，Verify whether the company exists & ldquo;Stake Sports Betting、& ldquo; Ticket & rdquo;My stake betting app、Rental lending licenses and purchasing drugs from illegal channels and other illegal behaviors and other illegal behaviors。

 

  2. Data comparison。Many seemingly powerful pharmaceutical companies pour in the official GMP routine in Europe and the United States，Electronic data、Records quickly become the focus of the attention of pharmaceutical people。Reference data checking method in the production field，This special rectification will also be data -based comparison of electronic data of drug circulation enterprises。For example，The same business situation、In the case of not much difference in purchasing and selling data，Verify whether the data of each enterprise has multiple sets of accounts。

 

 3. December traceability。This special rectification，In most cases, it is checked by the Stake Sports Bettingdrug use unit (individual clinic) or terminal pharmacies，Through the drug use unit (individual clinic) or terminal pharmacy verifies the specific situation，Tracing of various drugs wholesale、Whether the chain company operates compliant。For example，In a pharmaceutical use unit (individual clinic) or terminal pharmacy, it cannot be provided stake sports betting appby its withdrawal of the accompanying counter (ticket)，Feedback of the drug use unit (individual clinic) or terminal pharmacy，Requesting relevant evidence (taking pictures or recording)，Tattage back to the wholesale of various drugs provided by the drug、Chain Enterprise。

 

  4. Extension survey。According to the author's understanding，When special rectification in the field of drug circulation in various drug supervision and management departments，R & D of various medicines、Inspection in the production field has never stopped。Each drug supervision and administration department is developing drugs、During the inspection of the production enterprise, he found major problems，Will ask for drug research and development、The sales flow of the manufacturer，According to its sales flow direction，Check the wholesale related drugs、Is the chain & ldquo;、Compliance operation。