To further strengthen the work of drug electronic supervision，Continuously improve the safety level of public medication，Promote social harmony and stability，Realize the entire process of the entire variety of drugs，According to the Party Central Committee、Relevant policies and policies and policies of the State Council and "National Drug Safety" Twelfth Five -Year Plan "，Develop this plan。
1. The status quo of the drug electronic supervision
The National Bureau has implemented the implementation of pharmaceutical electronic supervision work since 2006，until the end of February 2012，Anesthesia drugs in three phases、Psychiatric drugs、Blood Products、Chinese medicine injection、Vaccine、All varieties of basic drugs are included in electronic supervision。Phase 1，Anesthesia drugs、The first category of psychotropic drug preparations and small packaging raw materials will be included in electronic supervision since November 1, 2007，19 involved in pharmaceutical manufacturers，Drug approval number 72，3 national wholesale companies，599 regional wholesale companies。Issue 2，The second type of psychotropic medicine、Chinese medicine injection、Blood Products、The vaccine will be included in electronic supervision since November 1, 2008，568 drug manufacturers involved，There are 2471 drug approval text; 13,000 drug wholesale enterprises (including illegal persons)。No. 3，All national basic drugs are included in electronic supervision before the end of February 2012，More than 2,800 drug manufacturers involved，Drug approval number is about 54,000。At the same time, it will also contain ephedra -alkaline compound preparations before December 31, 2011、Including the rescue solution of compound oral、Three -type drugs with Di Fen Fenolytic Preparations are included in electronic supervision，Nearly 600 pharmaceutical manufacturers，Nearly 2000 drugs for the drug approval。As of the end of February 2012，It has been included in electronic supervision drugs involving the approval number 56,000。According to the National Bureau's "Notice on the Implementation of the Issues Related to the Supervision of Drugs and Electronics" (National Food and Drug Administration Office [2008] No. 165), "gradually the production of registered medicines and medical devices will be gradually approved、Work requirements for operating in electronic supervision，A total of 119,000 pharmaceutical preparation approval numbers that have not yet been included in electronic supervision，Drug preparations have been admitted to 32%of all drug preparations; about 4600 pharmaceutical preparation manufacturers，Among them, more than 2,900 have been entered into the Internet，accounting for 63%of the total number of manufacturers; all drug wholesale enterprises have entered the Internet。
2. Guiding thought
Guided by Deng Xiaoping theory and the important idea of "three representatives"，Carefully implement the concept of scientific development，The responsibility of fully fulfilling government social management and public services，Strengthen the construction of drug supervision infrastructure，Improve the technical standard system，Vigorously improve the level of supervision technology，Innovation supervision mechanism，Standardized supervision behavior，Improve supervision ability and level，Safety of public medication，Contributions to the comprehensive construction of a well -off society Stake Sports Bettingand My stake betting appthe construction of a harmonious socialist society。
Three, work target
Master target: Electronic supervision of the entire process of the entire variety of drugs by the end of 2015，Guarantee drugs are producing、circulation、Use safety in each link，Most powerful combat fake and inferior drug behavior、The fastest realization of the traceability and recall of the drug medicine、Maximize the legal interests of the enterprise，Ensure the safety of the people's medication。
Specific goals include:
(1) Anesthesia drugs currently implemented、Psychiatric drugs、Blood Products、Chinese medicine injection、Vaccine、Based on the electronic supervision of basic drugs for basic drugs，Gradually promoted to other drug preparations，All kinds of all kinds of pharmaceutical electronic supervision; launch high -risk medical device electronic supervision pilot work in a timely manner，Explore the electronic supervision of the raw and medicine。
(2) Drug production currently implemented、Based on the electronic supervision of the wholesale link，Promoting to pharmaceutical retail and use links，Therefore, covering production enterprises、Wholesale Enterprise、Retail pharmacy、Drug production of medical institutions、Tracing of the entire process of circulation and use。
According to the overall deployment of the Ministry of Health，Carrying out the medical institution's pharmaceutical electronic supervision work。
(3) In -depth application of expanding the electronic supervision system of the drug，Make full use of drug electronic supervision data，Provide decision -making support services for governments and regulators at all levels，Provide drug information retrieval for the general public、Supervision code query、Authenticity identification and other services，Exploring the feasibility of interconnection of the electronic supervision system and the medical insurance card system。
4. Main task
(1) Formulate regulatory documents to promote the supervision of drugs and electronic supervision
Implement "National Drug Safety" Twelfth Five -Year Plan "，further clarify the necessity of drug electronic supervision in the revision of relevant laws and regulations such as the "Drug Management Law"。Summarize problems in the implementation of drug electronic supervision，Cooperate with the overall work deployment，Formulate supporting policy and regulations documents，Clear policy requirements and management specifications，Timely organize promotion and training，Make sure that each specific work content and tasks are implemented。
(2) Formulate a standard specification system
The standard specification system is an important guarantee for the participants of stake betting appthe pharmaceutical electronic supervision work to carry out work under the unified management and technical framework。Further formulate and improve the standard standard system related to unified drug electronic supervision，Including business specifications、Data Standard specification、Information security standard specifications, etc.，To ensure the smooth implementation of drugs and electronic supervision，Ensure reasonable development and use of drug supervision information resources，Ensure that the drug electronic supervision information system is interconnected with other information systems、Interoperability and Sharing。
1. Business specifications。Including business system access based on unified identity authentication and authorization services、Data collection and report operation、Data utilization specifications, etc.。
2． Data Standard specification。Including data coding specifications、Data interface standard、Data exchange format standard、Information classification and code standard、metadata data standards, etc.。
3. Information Security Standard Specification。It mainly includes the protection specifications of information system security level、Safety management specifications、Network Security specification、Application Safety Specification、Data security specifications and physical security specifications。
(3) Improve the infrastructure of drug electronic supervision
Further improve the infrastructure of drug electronic supervision，Improve the reliability of the system、Practical、Easy to use、scalability and management，Complete the construction of the National Pharmaceutical Supervision Information System in the first phase of the National Pharmaceutical Supervision Information System approved by the National Development and Reform Commission。The main content includes:
1. Perfect and optimize stake betting appthe pharmaceutical electronic supervision stake sports betting appinformation platform，Build high performance、Distributed、intensive drug electronic supervision information platform，Provide safety、Control、Viewing and services based on identity certification。
2． Make full use of national e -government internal and external network resources，Further improve the network environment of drug electronic supervision，Realize all levels of government departments at all levels、Enterprise and the public divide according to security levels and permissions，Entering stake betting appthe pharmaceutical electronic supervision system from the Internet and the special network as needed，Sharing Drug Electronic Supervision Information Resources。
3． Further strengthen the construction of the information security guarantee system，According to the country's requirements for strengthening the security protection of the information system，According to the actual needs of drug electronic supervision work，Construction covers the physical environment of drug electronic supervision work、Network、System、Application and management information security system，Provide unified for drug stake sports betting appelectronic supervision、Stability、Efficient security guarantee system。
(4) Building drug electronic supervision information resource data center
Based on the database of drug electronic supervision，According to the unified data standard，Construction is from the Internet、Storage、Database、Data Electronic Supervision Information Resources Data Center composed of data warehouses，Integration of information resources，Realize the full sharing of information resources and use it reasonably。
The main construction content includes: covering a drug production enterprise、Business Enterprise、Medical institutions and other related units and consumers' pharmaceutical circulation data centers，Drug recall and emergency deployment data center，Data Analysis Center supported by statistical analysis and decision -support supporting drug electronic supervision data，Data Exchange and Sharing Center。
(5) Construction of Data Electronic Supervision Data Backup Center
Drug electronic supervision system and data are the core of normal operation of drug electronic supervision，To ensure the reliability of the electronic supervision business of drugs、usability and continuity，Gradually establish a central -level city and disaster recovery center;，Construction provinces、Autonomous Region、Data Backup of Pharmaceutical Electronic Supervision in the administrative area of municipality，Timely emergency response and recovery of emergencies and disasters。
(6) Construction of the electronic supervision service system
The number of enterprises and institutions incorporated into electronic supervision is increasingly larger，To ensure the quality of the drug electronic supervision platform，Construction with a call center、SMS platforms and instant messaging platforms, such as the core supporting service system，Timely respond to regulatory departments at all levels、Production enterprise、Business Enterprise、Daily consultation and problem complaints of medical institutions and the public in the process of using the drug electronic supervision system，Collect and handle relevant suggestions and feedback。
(7) Improve the function of the electronic supervision application system
With the development of drug electronic supervision, it develops in depth，You need to further expand the supervision of the drug electronic supervision application system、Service and auxiliary decision -making functions，To cope with the increasingly complex drug supervision situation。The main construction content includes:
1. Further improve the drug circulation supervision system，to support the supervision of the entire process of medicine，Streaming of the circulation of drugs in complete preservation，Make sure illegal drugs cannot enter legal circulation channels。
2． Construction data sharing and exchange system，Effective sharing of drug electronic supervision data，Easy to facilitate the extension of food and drug supervision departments at all levels。
3． Expand the mobile law enforcement system，Provides timely information support for law enforcement officers，Improve the convenience of law enforcement，Increase enforcement strength。
4. Based on the drug circulation supervision system，Construction of a social emergency system。Further improve the function of drug recall，Once a drug safety event occurs，Can recall the problem medicine as soon as possible，Control development，Maximum reduction in the loss of drug safety incidents to the health of the people。further realization of drug deployment functions，Once a sudden disaster occurs，You can quickly perform drug inventory positioning and unified deployment。
Stake Sports Betting5． My stake betting appConstruction auxiliary decision support system，Can be able to conduct statistical analysis of the status and operation status of drugs and electronic supervision，Provide assistance decision support for the improvement of drug supervision policies。
6. Building a drug electronic supervision public service platform，Provide drug information retrieval to the public、Supervision code query、Authenticity identification and other services，Ensure the safety of public medication。
5. Work arrangements
(1) Construction of the National Pharmaceutical Electronic Supervision Platform in 2012
Approval of the first phase of the National Drug Supervision Information System according to the National Development and Reform Commission，Construction of stake betting appthe pharmaceutical electronic supervision platform，Use information technology，Auxiliary solution in drug production、circulation、Use security problems existing in each link，Ensure the safety and effectiveness of the people's medication。
In the first half of 20112
Complete the construction of information resource data centers and different places and city backup centers before the end of 2012;
The construction of stake betting appthe pharmaceutical electronic supervision platform before the end of 3.2012，Improve the infrastructure of drug electronic supervision，Further constructing and improving the functions of the drug electronic supervision application system。
(2) 2012-2015 Achievement Drug Preparation (including imported drugs) all varieties of electronic supervision
1. Complete the implementation of the electronic supervision of the entire variety of basic drugs before February 29, 2012;
2. Complete the implementation of local supplements for basic drug electronic supervision before February 28, 2013，Start the electronic supervision of the entire variety of drug preparations;
Complete the electronic supervision of the entire variety of drug preparations before the end of 2015。
(3) Implement the entire process of electronic supervision by the end of 2015
Based on the implementation of electronic supervision in the production enterprise and wholesale enterprises，To retail pharmacy、Extension of the use links of medical institutions and other end -of -end circulation。
1. Wholesale Enterprise Pharmaceutical Electronic Supervision Work Arrangement
By the end of 2012，All wholesale enterprises carry out the implementation of drug electronic supervision in accordance with regulations，Calculating all coded drugs for verification，To "see the code must scan"。
2． Retail pharmacy electronic supervision work arrangement
(1) In the first half of 2012, the unified bidding and equipment of some retail pharmacies (47595) pharmaceutical electronic supervision My stake betting appSoftware and hardware equipment in the 12 provinces in the west were completed in the first half of 2012;
(2) Complete the electronic supervision and implementation of some retail pharmacies in the 12 provinces of the western 12 provinces by the end of 2012;
(3) Based on summing up the pilot work of retail pharmacies by the end of 2013，Expand the scope of pilot range of retail pharmacies;
(4) The implementation of electronic supervision of all retail pharmacies nationwide by the end of 2015。
3. Medical institution's electronic supervision work arrangement
According to the overall deployment of the Ministry of Health，Carry out electronic supervision work of medical institutions。
(4) Timely launch high -risk medical device electronic supervision pilot work，Explore the electronic supervision of the raw and medicine。
6. Guarantee measures
(1) Organization guarantee
Under the leadership of the Leading Group of the National Bureau of Informatization，The Information Office is responsible for electronic supervision and deployment、Plan、Inspection and other tasks; the system operating unit is responsible for the construction of the Drug Electronics Regulatory Network、Operation and maintenance and daily work; relevant departments are responsible for the management and use of the Drug Electronics Regulatory Network in accordance with the functions，Strengthen the integration of drug electronic supervision and daily supervision of drugs，Application needs for electronic supervision networks; food and drug supervision departments at all levels according to the overall deployment and work arrangement of the State Administration，Do a good job of implementing drug electronic supervision in the administrative area、Management、Application and extension。The scientific nature of ensuring drug electronic supervision，Establish an expert consultation group，from well -known domestic business experts、Technical expert composition，The main task is to study the opinions and suggestions of implementing drug electronic supervision，Review and evaluation related important policies and important matters。
(2) Fund guarantee
Drug electronic supervision work requires sufficient funds，Guarantee of the construction of drug electronic supervision network、Operation、Promotion training and development of daily work。Construction funds for construction projects related to pharmaceutical stake sports betting appelectronic supervision、My stake betting appSoftware and hardware equipment purchase、System integration and other projects。Operating funds for technical operation and maintenance of drug electronic supervision network、Call Center customer service support and digital certificate (key) for the network access institution。Promotion training funds for related training required for drug electronic supervision and promotion。Daily work funding for electronic supervision related work。
The above funds are combined with different situations in various regions，Coordinate with relevant departments in various places，Use a variety of ways to solve。During the promotion of drug electronic supervision work，According to "special funds，Audit Supervision "principle，Accept the supervision of the use of funds by the audit department and the disciplinary inspection department。
(3) Technical guarantee
Planning of Drug Electronics Regulatory Network、Analysis、Design、Implement、Operation、Maintenance、Training needs to provide comprehensive technical guarantee measures。State Administration Coordinated Plan，Organization experts carry out overall plan、Demand analysis、System feasibility research and system design; local bureaus must assign special personnel to cooperate with relevant technical guarantee measures to implement in the administrative area;、Technical guarantee services such as operation and maintenance，Provide professional training。
