Deputy Director of Food and Drug Administration: Do a good job of basic medicine supervision is the focus of work in the second half of the year
Release time: 2011-07-13 & nbsp & nbsp & nbsp Source:
Business Club, July 12th Wu Yan emphasized，First, pay close attention to the winning bid price of basic drugs; second, it is necessary to effectively carry out production site inspections; third, try cross -regional supervision and inspection
July 7，Symposium on the National Food and Drug Supervision and Administration in 2011, which lasted 3 days, ended successfully。Wu Yan, deputy director of the National Food and Drug Administration (SFDA), pointed out in a summary speech，Go all the way to grasp the basic drug supervision work is the focus of work in the second half of the year。
The national basic drug system has been implemented for nearly 2 years。During the period，stake online sports bettingSome Stake Sports Bettingsupporting measures have also been improved one after another，The supporting work of basic drug supervision is actively promoted。To strengthen the communication and application of basic drug drawing information，Timely understanding the progress of the work of basic drugs in various places，SFDA organization developed the national basic drug drawing information system。The system has been officially enabled a few days ago。At the same time，sfda also issued a notice，Requirement。
"Current，The progress of basic drug supervision is generally good，But you must not take it lightly。"Wu Yan talked about，Some time before，SFDA organized a special inspection，I found some problems and signs，It indicates that there are potential risks in the production process of basic drugs。So，Food and drug supervision departments at all levels must be highly political responsibility，Carefully do a good job of quality supervision of basic drugs。
Wu Yan emphasized，In the second half of the year，Pay special attention to the following aspects: First, pay close attention to the winning bid price of basic drugs。The varieties that are significantly lower than the cost of winning bids are listed as the key supervision and inspection objects。All localities should pay attention to the winning bid price of production enterprises in their jurisdictions，To do the necessary horizontal comparison。Products with obvious low prices，To organize inspections in time。Resolutely prevent it from charging for the second time、Alternative My stake betting appinvestment、Stake Sports BettingDelivery，Even if you do not feed, such problems occur。To prevent the possibility of potential drug safety risks later。
Second, it is necessary to effectively carry out production site inspections。Wu Yan pointed out，Basic drug production site inspection is different from GMP inspection。GMP is compared with the process standard，But the on -site examination of basic drugs is targeted。According to the characteristics of basic drugs and possible problems，Organize in a targeted manner。To check the source of raw materials，Make sure the quality of raw materials; check the material balance，Guarantee sufficient amount of feeding; check the process，Prevent cutting corners。Suspicious points found on on -site inspections、Question clues，Never let go of it easily，It must be investigated and deeply investigated，Control hidden safety hazards as possible，Eliminate quality and safety risk。Production on violations of laws and regulations、There are subjective intentional plots，Strip from punishment in accordance with the law，until the approval number is revoked，A revoking production license，Responsible for the relevant personnel。
Third is to try cross -regional supervision and inspection。It is reported，At present, some provinces and cities have made positive explorations in strengthening basic drug supervision。
If the Shaanxi Provincial Bureau has carried out basic drug production technology and prescription verification，and further strengthen the supervision of the basic drug production stake sports betting appsite。Never maliciously reduce stake online sports bettingcosts to prevent individual enterprises in order to prevent individual enterprises，The bureau implements cost monitoring system for the implementation of traditional Chinese medicine preparations in basic drugs。Report product cost information from basic drug manufacturers，The drug supervision department is based on information collected from various channels，On -site verification of the production cost of the enterprise。At the same time, it also specially strengthened the supervision of the bidding enterprises in basic drugs in other provinces，It is required that the enterprise will issue a proof document for the basic drugs that have implemented the production process and prescription verification、Production and quality control reports and re -evaluation materials，And verified，If necessary, take on -site verification and other measures。
Yunnan Province has formulated the "Implementation Rules for the Implementation of Basic Drug Sample File"，At the same time, strengthen the pumping test of the quality of drug supply after the listing of the bidding varieties，If necessary, extract the same variety filing sample for comparison and testing。
According to the principles of territorial regulation，Provincial (district、City) Bureau is the responsible department of the basic drug quality supervision of the area under its jurisdiction，A major responsibility。Wu Yan emphasized，Current，Drugs have formed a large market、Big circulation pattern，Production of basic drugs、Circulation My stake betting appis also for the national stake betting appmarket，So，While trying to ensure the quality and safety of the basic drugs in the area under its jurisdiction，It is also necessary to strengthen the supervision of the basic drugs entering the area under its jurisdiction。Wu Yan encourages regulatory departments in various places to start brain tendon，Strengthen cooperation between regional supervision，Actively explore and boldly try to cross -regional basic drug supervision and inspection。(Author: Wei Yan)
July 7，Symposium on the National Food and Drug Supervision and Administration in 2011, which lasted 3 days, ended successfully。Wu Yan, deputy director of the National Food and Drug Administration (SFDA), pointed out in a summary speech，Go all the way to grasp the basic drug supervision work is the focus of work in the second half of the year。
The national basic drug system has been implemented for nearly 2 years。During the period，stake online sports bettingSome Stake Sports Bettingsupporting measures have also been improved one after another，The supporting work of basic drug supervision is actively promoted。To strengthen the communication and application of basic drug drawing information，Timely understanding the progress of the work of basic drugs in various places，SFDA organization developed the national basic drug drawing information system。The system has been officially enabled a few days ago。At the same time，sfda also issued a notice，Requirement。
"Current，The progress of basic drug supervision is generally good，But you must not take it lightly。"Wu Yan talked about，Some time before，SFDA organized a special inspection，I found some problems and signs，It indicates that there are potential risks in the production process of basic drugs。So，Food and drug supervision departments at all levels must be highly political responsibility，Carefully do a good job of quality supervision of basic drugs。
Wu Yan emphasized，In the second half of the year，Pay special attention to the following aspects: First, pay close attention to the winning bid price of basic drugs。The varieties that are significantly lower than the cost of winning bids are listed as the key supervision and inspection objects。All localities should pay attention to the winning bid price of production enterprises in their jurisdictions，To do the necessary horizontal comparison。Products with obvious low prices，To organize inspections in time。Resolutely prevent it from charging for the second time、Alternative My stake betting appinvestment、Stake Sports BettingDelivery，Even if you do not feed, such problems occur。To prevent the possibility of potential drug safety risks later。
Second, it is necessary to effectively carry out production site inspections。Wu Yan pointed out，Basic drug production site inspection is different from GMP inspection。GMP is compared with the process standard，But the on -site examination of basic drugs is targeted。According to the characteristics of basic drugs and possible problems，Organize in a targeted manner。To check the source of raw materials，Make sure the quality of raw materials; check the material balance，Guarantee sufficient amount of feeding; check the process，Prevent cutting corners。Suspicious points found on on -site inspections、Question clues，Never let go of it easily，It must be investigated and deeply investigated，Control hidden safety hazards as possible，Eliminate quality and safety risk。Production on violations of laws and regulations、There are subjective intentional plots，Strip from punishment in accordance with the law，until the approval number is revoked，A revoking production license，Responsible for the relevant personnel。
Third is to try cross -regional supervision and inspection。It is reported，At present, some provinces and cities have made positive explorations in strengthening basic drug supervision。
If the Shaanxi Provincial Bureau has carried out basic drug production technology and prescription verification，and further strengthen the supervision of the basic drug production stake sports betting appsite。Never maliciously reduce stake online sports bettingcosts to prevent individual enterprises in order to prevent individual enterprises，The bureau implements cost monitoring system for the implementation of traditional Chinese medicine preparations in basic drugs。Report product cost information from basic drug manufacturers，The drug supervision department is based on information collected from various channels，On -site verification of the production cost of the enterprise。At the same time, it also specially strengthened the supervision of the bidding enterprises in basic drugs in other provinces，It is required that the enterprise will issue a proof document for the basic drugs that have implemented the production process and prescription verification、Production and quality control reports and re -evaluation materials，And verified，If necessary, take on -site verification and other measures。
Yunnan Province has formulated the "Implementation Rules for the Implementation of Basic Drug Sample File"，At the same time, strengthen the pumping test of the quality of drug supply after the listing of the bidding varieties，If necessary, extract the same variety filing sample for comparison and testing。
According to the principles of territorial regulation，Provincial (district、City) Bureau is the responsible department of the basic drug quality supervision of the area under its jurisdiction，A major responsibility。Wu Yan emphasized，Current，Drugs have formed a large market、Big circulation pattern，Production of basic drugs、Circulation My stake betting appis also for the national stake betting appmarket，So，While trying to ensure the quality and safety of the basic drugs in the area under its jurisdiction，It is also necessary to strengthen the supervision of the basic drugs entering the area under its jurisdiction。Wu Yan encourages regulatory departments in various places to start brain tendon，Strengthen cooperation between regional supervision，Actively explore and boldly try to cross -regional basic drug supervision and inspection。(Author: Wei Yan)
