According to the China Government Network News，The State Council recently issued the "Twelfth Five -Year Plan" plan for the National Drug Safety。Plan introduced the current drug safety situation，and propose the specific goal of national drug safety development during the "Twelfth Five -Year Plan" period。The full text is as follows:
National Drug Safety "Twelfth Five -Year Plan
Drug safety is a major issue of people's livelihood and public safety，Reasoning about the health and social harmony and stability of the people。To further improve my country's drug safety level，Maintain the health rights and interests of the people，Promoting the sustainable and healthy development of the pharmaceutical industry，According to the "Outline of the Twelfth Five -Year Planning of the National Economic and Social Development of the People's Republic of China" and the Party Central Committee、Relevant policies and policies of the State Council，Develop this plan。
1. Drug safety situation
(1) The achievements obtained。"Eleventh Five -Year Plan" period，The country has introduced a series of policy measures，Increasing government investment，Forms a relatively complete pharmaceutical production and supply system，Basically established coverage of drug development、Production、The safety supervision system of circulation and use the whole process，Drug safety status has improved significantly，Drug safety guarantee capabilities have improved significantly。
1. The status of drug safety has improved significantly。The total pass rate of the national drug evaluation test has increased significantly，Chemical drugs、Chinese medicine、The qualification rate of biological products has increased significantly，Maintain a good level in general。"Administrative Measures for the Registration of Drugs" After the revision and implementation in 2007，Raising the registration approval standard，Strict drug production access，The quality of newly listed generic drugs has increased significantly。Drug adverse reaction monitoring、Special drug abuse monitoring network warning effects enhanced，Drug safety incident emergency response ability has been greatly improved，Drug safety incidents gradually decrease。
2. Public medication needs basically meet。Implement the national basic drug system，Guarantee the public's basic medication rights。New drug creation ability is further improved，Pharmaceutical modern logistics system construction steadily advance，The drug supply network covering urban and rural areas is basically completed，Public daily medication needs are basically met。Established a national pharmaceutical reserve system，Improving the drug guarantee ability to deal with major epidemic disasters。
3. Drug safety supervision ability has increased significantly。Create a relatively complete country、Provincial、City、County 4th level administrative supervision system，Building a drug registration review、Standard formulation、Test test、The technical support system focusing on the monitoring of adverse reactions，A sound laws and regulations with the "Pharmaceutical Management Law of the People's Republic of China" and "Regulations on the Supervision and Administration of Medical Device" as the core，formed a national drug standard management system with "Pharmacopoeia of the People's Republic of China"。Further improved the quality management specifications of drugs，Enhanced the entire process of drugs。Drug supervision informatization construction has achieved staged results，Electronic supervision of special drugs is promoted smoothly。Drug supervision infrastructure has improved significantly，Team quality has improved significantly。
(2) Existing problems。Insufficient R & D investment in pharmaceutical production enterprises，Innovation ability is not strong，The quality of some generic drugs and the international advanced level is large gap。The current pharmaceutical market mechanism is not sound，Drug prices and tender mechanisms are incomplete，Some companies pursue economic benefits one -sided pursuit，Sacrifice quality production drugs。Medical institutions have not improved significantly with the status of medicine for medicine，Clinical medication supervision needs to be further strengthened，Insufficient guidance of retail pharmacies and hospital pharmacies and pharmacists，Unreasonable medication is more serious。Fake phenomenon of illegal elements sells fake drugs frequently，Use the Internet、Mailing and other methods to sell fakes is increasing，Some fake drugs even enter the regular circulation channel of drugs，Drug safety risk is still large。At the same time，Drug safety legal system is not perfect，The technical support system is not sound，Performance of law enforcement forces，Drug supervision ability is still relatively lagging。
"Twelfth Five -Year Plan" period is a critical period for my country's comprehensive construction of a well -off society，It is also an important opportunity period for promoting the healthy and rapid development of the pharmaceutical industry。With the further development of my country's economy and society，improvement of the quality of life of residents，The people of the people for the safety of medicines、The requirements of the availability and nature are continuously improved。Population aging、Disease spectrum changes、Frequent contagious diseases such as new hair，New challenges to drug safety。At the same time，The rapid development of the pharmaceutical industry，Industrial structure adjustment，High -tech is widely used in the pharmaceutical industry，All have put forward higher requirements for drug safety supervision。Must further strengthen drug safety work，Provide a powerful guarantee for the health of the people。
2. Guiding thoughts, basic principles and development goals
(1) Guidance.
Guided by Deng Xiaoping theory and the important idea of "three representatives"，In -depth implementation of the concept of scientific development，Combining the reform of the medical and health system in combination，Comprehensive improvement of drug standards，Further improve the quality of drugs，Improve the drug supervision system，Standardized Drug Development、Production、circulation and use，Implementation of drug safety liability，Strengthening the construction of the technical support system，Improve drug safety guarantee capabilities，Reduce drug safety risk，Ensure the safety of the people's medication。
(2) Basic principles.
1. Adhere to safety first，Scientific Supervision。To ensure stake online sports bettingthe safety of people's medication as the fundamental purpose，To improve the standards of drugs and drug quality as the focus of work，Improve the regulatory system，Innovation supervision mechanism，Scientific implementation of supervision in accordance with the law。
2. Persist in strict law enforcement，Standard order。Establish and improve science、Justice、Public、Efficient Drug Safety Law Enforcement System，Strict cracking down on fake and inferior drugs，serious accountability for drug safety，Promoting the order and security situation of the drug market continued to improve。
3. Adhere to strengthening the foundation，Improve ability。Strengthen the infrastructure of drug safety guarantee，Improve the supporting system of drug supervision technology，Enrich supervisory force，Improve the quality of the team，Improve regulatory efficiency。
4. Adhere to unified coordination，Division of labor is responsible。Strengthening government drug safety responsibility at all levels，Implementation of division of division of responsibilities，Establish a unified and coordinated department linkage mechanism，Joint enforcement，Grabbing together，Realize the fields of drug safety、Comprehensive and effective supervision of each link。
(3) Development goals.
1. Overall goal.
After 5 years of hard work，Drug standards and drug quality have increased significantly，The drug supervision system is further improved，Drug Development、Production、Further specifications for circulation order and use behavior，Drug safety guarantee capabilities are close to international advanced levels，Drug safety level and people's medication safety satisfaction significantly improved。
2. Planning indicators.
(1) All chemicals、Biological products standards have reached or close to international standards，Traditional Chinese Medicine Standard Leading International Standards。The proportion of medical devices adopts an international standard of more than 90%。
(2) The "Administrative Measures for the Registration of Drug Registration" revised in 2007 in the imitation drugs approved before the implementation of it，The quality of national basic drugs and clinical common drugs reaches international advanced level。
(3) 100%of drug production meets the requirements of the "Medical Quality Management Specifications" revised in 2010; 100%of the production of sterile and implanted medical device production meets the requirements of the "Management of Quality Management of Medical Devices"。
(4) 100%of drug operations meet the requirements。
(5) The newly opened retail pharmacies are equipped with practicing pharmacists。2015 retail pharmacies and hospital pharmacies all realized the guidance of practicing pharmacists for reasonable medication。
3. Main tasks and key projects
(1) Comprehensively improve national drug standards.
Implementation of national drug standards improvement action plans。Refer to international standards，Priority to improve the quality standards for basic drugs and high -risk drugs。Improve Chinese Chinese (Material)、Ethnic medicine (materials) quality standards and specifications for the processing。Drug production must strictly implement national standards，Can't meet the national standard，Nothing must be produced、Sales and use。Strengthen State Drug Standards，Focus on strengthening safety indicators research。
Implementation of national medical device standards to improve action plan。Priority to improve the general standard of medical device foundation，Improving standards for high -risk products and large market usage products。Strengthening medical device detection technology and method research，Extract the scientific nature of the standard。Accelerate the study of standard material research and reference survey laboratory。
Comprehensively improve the quality of generic drugs。The "Measures for the Management of Drug Registration" revised in 2007 before the implementation of the imitation drugs，Evaluation of quality consistency in stages with imitation drugs，Among them, it is included in the national basic drug directory、The commonly used generic drugs commonly used in clinical clinical was completed by 2015，If the evaluation of the quality consistency is not registered，Log canceling its drug approval certificate。Pharmaceutical manufacturers must accord，Comprehensively compare the generic drugs produced with generic drugs with generic drugs，As the basis for the application and register。
Improve the national pharmaceutical standard management system with "Pharmacopoeia of the People's Republic of China"。Drugs、Management Measures for Standards for Medical Devices，Improved medicine、Formulation of medical equipment standard、Revision、Published、Implement、Abandoned Program，Establish Standard Evaluation、Demonstration mechanism。Strengthen the construction of medical device standard management institutions。Establish government -led，Enterprise、Inspection agency、Standard improvement mechanism jointly participated by universities and scientific research institutions，Guide and encourage enterprises to improve quality standards through technological progress。
Column 1: National Medicine、Medical Device Standards Improve Action Plan
Improve drug standards: Complete 6,500 drug standards to improve work，Among them, 2500 chemicals、2800 Chinese medicines、200 biological products、350 Chinese medicinal materials、650 Chinese medicine drinks。Improve 139 packaging materials for direct contact with drugs，Formulate 100 commonly used directly -contact drugs for packaging materials。Improve 132 pharmaceutical accessories standards，Develop 200 medicinal auxiliary materials standards。
Improve medical device standards: 150 items for completing medical electrical equipment standards、Standard for passive medical device products 250 items、Diagnostic reagent product standards 100 items。Complete General Safety Standards for Medical Electric Equipment (3rd Edition)、Electromagnetic compatibility standard system (repair) booking。Improve the standard material research working mechanism，Develop 15 standard substances for medical devices。
(2) Strengthen the quality supervision of the entire process of drugs.
Strict drug development supervision。Improve the development of drugs，Data management standards and data management standards，Promote the international recognition of data。Establish and improve the non -clinical safety evaluation laboratory、The supervision and inspection system and regulatory mechanism of the drug clinical trial institution，Explore the establishment of a hierarchical classification supervision and management system。Improve the coverage of drug clinical trials，Monitoring of Safety Data of Drug Clinical Test。Non -clinical research data applied for all new drugs must be derived from institutions that comply with the "Specifications for Quality Management of Drugs"。Encourage rare diseases and appropriate dosage development。Strengthen the protection of the subject，Improve the social participation and risk management level of clinical trials of drugs。Strengthen the management of clinical trials of medical equipment，Formulate quality management specifications。Strengthening the principle of review and guidance of medical device registered technology Stake Sports Bettingreview and guidance，Unified medical device review standard，Improve review ability。
Strict drug production supervision。Strengthening the construction of drug production supervision system，Focus on promoting production quality management specification certification work，Establish and improve the drug production risk supervision system。Encourage the development of commonly used traditional Chinese medicinal production technology research，Promote the implementation of the quality management specifications of the production of Chinese medicinal materials，Encourage Chinese medicine production enterprises to establish a medicinal material base in accordance with the requirements。Improve the quality management system of medical equipment，Prepare the Guidelines for Implementation of the Quality Management Standards for Medical Devices for key varieties。Strengthen drugs、Regular inspections of medical device manufacturers implement the standardization of production quality management specifications，Serious investigation and punishment illegal enterprise。Strengthen imported drug supervision，Establish and improve overseas inspection working mechanism and specification，Explore the establishment of an export drug supervision system，Promoting the construction of the network and export and customs of drug imports and exports，Establish and improve the classification management of import and export medical equipment、Entry -exit Verification and Risk Management System。
Strict drug circulation supervision。Improve the drug business license system、Drug operation quality management specification certification system。Improve the drug circulation system，Standardize circulation order，Encourage pharmaceutical manufacturers to deliver directly，and settle directly with drug retail institutions。Develop Drug Modern Logistics and Chain Operation，Formation of the relevant standards of the cold chain logistics of drugs。Explore the establishment of the traceability system of the circulation traceability of Chinese medicinal materials。Formulate the implementation of high -risk medical device business quality management specifications，Improve the entry threshold for medical device business enterprises，Perfect the exit mechanism。Improve the basic drug supply network，Establish and improve the coordination mechanism for the supply guarantee guarantee for shortage of shortages，Make sure the quality and safety of basic drugs and shortage drugs、fairness and。
Strict drug use supervision。Improve the quality management system of the drug use link，Strengthen the quality management of medical institutions and retail pharmacies，Give full play to the guidance of the medicinal pharmacist，Standardize the doctor's prescription behavior，Practical reduction of unreasonable medication。Strengthen the supervision of medical device，Perfect the management system of medical device。Carry out drug safety publicity and education activities，Popularized common sense of drug safety，Improve public safety consciousness，Promote reasonable medication。
(3) Improve the drug inspection and testing system.
Improve the work mechanism of the medicine drawing，Expansion of the scope of the coverage of the drawing and the variety of pumping varieties，Increase the frequency of drawing。Pharmaceutical drawing must be inspected、Inspection procedures open，Inspection results, announce in time。Unqualified product，Time to deal with it in time。
Improve the ability of drug inspection。to the end of "Twelfth Five -Year Plan"，Provincial Pharmaceutical Inspection Agency、Portal drug inspection agencies have the full inspection ability of chemicals and Chinese medicine in accordance with legal standards，Municipal -level pharmaceutical inspection agencies have more than 85%of projects for inspection capabilities。Strengthening biological products approval and issuing inspection ability，Authorized some provincial pharmaceutical inspection institutions undertake biological products approval tasks，The authorized institution must have the independent inspection ability of the authorized variety。Performance of drugs for drugs、Drug fast test technology and supplementary inspection technology research，Building a inspection technology sharing platform。
Improve medical equipment detection ability，Focus on improving high -risk products such as implantation medical equipment and electrical safety、Electromagnetic compatibility、The detection ability of biological safety。Strengthen the qualification recognition and supervision review of medical device testing agencies，Establish an exit mechanism。to the end of "Twelfth Five -Year Plan"，National medical device detection institution has the ability to detect all food products，Provincial medical device detection institutions have the detection ability of more than 95%of common medical equipment。
(4) Improve the level of drug safety monitoring and early warning.
Strengthen the monitoring of adverse reactions of grassroots medicines，Improve the monitoring mechanism combined with key monitoring and daily monitoring，Evaluation and early warning of adverse reactions and adverse events of drugs and medical equipment。Improved drug safety press release system，Publish drug safety early warning information。
Strengthening special drug abuse monitoring。Improve monitoring network and system，Establish a survey and monitoring mechanism for drug use for sensitive people，Provide technical services and guarantees for special drug supervision。
Improve the system after the drug is listed。Carry out drug safety risk analysis and evaluation，Focus on strengthening basic drugs、Chinese medicine injection、Safety evaluation of high -risk drugs。Achieve the technical support system for re -evaluation of drugs。Evaluation and determination of the efficacy is inaccurate、There are serious adverse reactions、Pharmaceuticals that are greater than clinical benefits endanger public health，All cancellation of drug approval documents。Establish a medical device re -evaluation system，Organize the re -evaluation of high -risk medical equipment。
Column II: Drugs after the listing of adverse reactions and security re -evaluation projects
Monitoring and re -evaluation of bad events of medical equipment: Select 100 varieties，Carry out key monitoring，Formulate monitoring technical specifications，Analysis report of safety risk analysis after completion of listing。
Improve the drug medical device monitoring agency: strengthen the construction of municipal and county -level monitoring agencies。Drug adverse reaction case county (city、District) The report ratio reaches 80%or more，The number of adverse reactions of the drug reaches 400 copies/million people。Medical Device Adverse Event County (City、District) The report ratio reaches more than 70%，The number of bad events of medical equipment reached 100 copies/million people。
(5) Strictly crack down on fake and inferior drugs in accordance with the law.
Deepen the special rectification of drug safety。Improve the system of combating the production and sales of the inter -ministerial coordination joint meeting，Improve departmental counterfeit collaboration mechanism，Construction of information platforms that accelerate the connection between administrative law enforcement and criminal justice。Improve the drug inspection and appraisal mechanism，Improve the timeliness of the test and identification stake online sports bettingof fake and inferior drugs。Strengthen administrative law enforcement supervision，Standardized law enforcement behavior，Production and operation enterprises for fake and inferior drugs，Revisit the approval document in accordance with the law。Improve the joint supervision case system，Increase the investigation of the case，Focus on cracking down on the production of fake and inferior drugs and using the Internet、mail、Hanging and other methods to sell fake and inferior drugs illegal and criminal behavior，Resolutely combat import and export fake inferior drugs illegal crimes。Research to solve the problem of too low conviction and sentence for production and sales of fake and inferior drugs，Increased punishment for the production and sales of fake inferior drugs illegal and criminal acts。Township (Town)、Village is the focus，Increased the strength of the grassroots fakes，Strictly cracking down on mobile pharmaceutical vendors。Standardize medicinal materials border trade。
Strictly crack down on illegal drug advertising behavior。Strict advertising approval，Improve the advertising monitoring network，Reinforced advertising before release specification guidance、Dynamic supervision during the release、After the release, investigate and deal with it in accordance with the law。Standardize online drug information services and advertising release behaviors，Focus on the use of the Internet to release false advertisements and false publicity behaviors。Strengthen drug e -commerce, especially online drug retail market supervision，Strict Internet drug trading service website qualification approval，Promoting the healthy development of Internet drug transactions services。
(6) Improve the drug safety emergency response system.
Perfect medicine、Emergency plans for emergencies in medical device，specification disposal procedures。Strengthen the emergency platform、Emergency inspection and other technical support system construction，Strengthen the Construction of Complaint Reporting Center of State Drug Safety Emergency Demolition and State Food and Drug Administration，Strengthen emergency management training，Improve emergency response capacity and level。Improve major emergencies emergency drug expansion and transformation and application for approval work mechanism，Ensure the timely effective supply of emergency drugs。
Column 3: Construction Project of Emergency Management System
Emergency exercise base construction: strengthen national medicine、Construction of medical device safety emergency exercise base，Carry out emergency knowledge and skills training，Organization emergency drill。
Equipment of emergency disposal equipment: for national level、Provincial emergency teams are equipped with necessary emergency equipment。
(7) Strengthen the construction of drug supervision infrastructure.
Accelerate the implementation of drug safety infrastructure construction projects，Strengthening technical review、Check certification、Monitoring and early warning infrastructure construction，Further improve the country、Provincial、Laboratory conditions of the city's third -level pharmaceutical inspection institution，Strengthen the construction of infrastructure construction at the provincial medical device testing center。Building a house for office business for the construction of a drug administrative supervision agency，Equipped with law enforcement equipment。Accelerate the application of the rapid testing technology at the grassroots level，Configure the quick inspection equipment。
Column 4: Construction Project of Drug Safety Infrastructure
Strengthen infrastructure construction: Strengthen the construction of business housing for drug administrative supervision institutions，Improve the country、Provincial level (including port)、Laboratory conditions of the city -level pharmaceutical inspection institution，Equipped inspection equipment，Improve the ability of the grassroots level at the grassroots level。Construction of provincial medical device detection institutions、Urban -level drug adverse reaction monitoring institutions infrastructure。
Strengthen law enforcement equipment and equipment: according to the standard standard，For the city、The county -level drug administrative supervision agency is equipped with necessary law enforcement equipment。
(8) Accelerate the construction of supervision informatization.
Promote the construction of the national pharmaceutical electronic supervision system，perfect coverage of the whole variety、The whole process、The pharmaceutical electronic regulatory system that can be traceable。Integrated information resources，Unified information standard，Construction Data Center，Gradually realize the docking of the national pharmaceutical electronic supervision system with the relevant departments and the corporate informatization system。Adopting information technology to realize non -on -site supervision of drug research and production process。Establish a sound medical device supervision information system，Start high -risk medical device national unified coding work。Complete the first phase of the national drug supervision information system，Start the construction of the second phase of the project。
Column 5: National Drug Supervision Information System II Project
Application platform construction: expand administrative law enforcement、Monitoring Analysis、Government Affairs Open、Social Emergency、Internal management and other five types of application platforms，Construction Data Center，Added auxiliary decision -making information platform。
Information System Construction: Establishing a drug non -clinical research、Drug Clinical Test、Drug production quality management supervision information system，Carry out advertising supervision、Medical institutions Reasonable Drug Supervision、Drug safety assessment and pilot medical equipment supervision。
Information Resource Security Construction: Improve the guarantee of drug supervision information resources and supporting environmental construction。
(9) Improve the quality of the talent team.
Formulate drug supervision mid- and long -term talent development plan，Establish strict personnel access、Training and management system。Strengthen the training of professional and technical personnel of the drug supervision department，Accelerate the training of high -level supervision talents and urgent need for special talents，Form a proper scale、Reasonable structure、Good quality drug supervision professional team。Construction of Senior Training College of the State Food and Drug Administration，Gradually form a national and provincial training architecture，Construction of network education training platform covering the entire system。Strengthen the leading cadres of the drug supervision department and the grassroots leader training，Improve the level of supervision。to the end of "Twelfth Five -Year Plan"，Drug supervision teams at all levels at all levels of college degree or above reaches more than 75%，Pharmacy、Medical Device、Medicine、Law and other related professionals reached more than 75%。
Column 6: The quality improvement project of the talent team
Basic Engineering of Talent Team: Strengthen the construction of infrastructure construction of the Senior Training College of the State Food and Drug Administration。confirmed in batches to stake online sports bettingconfirm that qualified institutions as cadres education and training bases for national food and drug supervision system。Construction Drug Supervision Discipline、Course、Teachers、Network training system。
Professional and technical personnel training project: Strengthen technical review、Check certification、Test test、Monitoring and early warning、Emergency Management、Policy research team construction and personnel training，Complete a new round of province、The main person in charge of the technical support agency of the city's two -level technical support institution。
Administrative Supervision Personnel Training Project: Complete a new round of provincial -level food and drug supervision institutions, members of the leadership team and city、The main person in charge of the administrative supervision agency at the county level。
Four, guarantee measures
(1) Perfect supporting policies to ensure drug safety。Improve the pharmaceutical industry policy，Improve the entry threshold，Strictly control the number of newly opened enterprises，Guide enterprises to merge and reorganize，Promote resources to focus on superior enterprises; support biomedicine、Health of the medical device industry、rapid development; vigorously support Chinese medicine、Development of National Medicine，Promoting inheritance and innovation。Research and improve the pharmaceutical economic policy，For generic drugs that have reached the international level，Prices at medicine、Bidding Purchase、Support for medical insurance reimbursement，Formation is conducive to improving drug quality、Incentive mechanism to ensure drug safety。Scientific and technological policy that improves drug safety，Strengthening the supporting role of technology on drug safety。Implementation of major national science and technology special projects and national science and technology plans for implementing major new drug creation，Support and encourage enterprise scientific and technological innovation，Improve medicine、Innovative ability of medical devices。Enterprise as the main body、Standardized approval procedures，Promoting drug safety research work。
(2) Improve drug safety laws and regulations。Promote the formulation of a practice pharmacist，Amend the "Drug Management Law of the People's Republic of China"。Amend the "Regulations on the Supervision and Administration of Medical Device"、"Administrative Measures for Radiory Drugs" and other regulations and regulations。Research and formulation prescription medicine and over -prescription drug classification management regulations。
(3) Strengthen the construction of drug safety supervision。Innovative drug safety law enforcement system mechanism，Promote the construction of a full -time drug inspector team。Enrich the national and provincial drug review evaluations、Check certification、Monitoring and early warning force，Make sure the medicine re -evaluates、Register and other jobs to carry out smoothly。Deepening the reform of the administrative approval system of drugs，Strict approval standards，Standardized approval procedures。Governments at all levels should incorporate the supervision of drug safety supervision into the fiscal budget，Increase funding investment。Strengthen the grassroots、Drug safety guarantee capabilities for remote areas and ethnic areas，Improve the conditions of grassroots law enforcement。Strengthen and International Organization、Exchange and cooperation of foreign regulators and civil institutions，Learn from international advanced supervision experience，Constantly improving supervision capabilities and levels。
(4) Comprehensive implementation of drug safety liability。According to the "Local Government Responsibility，Regulatory authorities are responsible for their responsibility，Enterprise is the requirements of the first responsible person "，Further improve the drug safety responsibility system。Enterprises must earnestly perform the responsibility of the main body of drug safety，Improve the quality management system，Strict implementation of quality management specifications，Forbidden drugs from exemption from factory、Sales，Timely recalling problem medicines and delisting drugs。Carry out the evaluation of corporate credit level，Establishing an integrity file for employees，Implement industry ban on enterprises and practitioners who have serious violations and dishonesty。The regulatory authorities must earnestly fulfill their supervision responsibilities，Strengthen the development of drugs、Production、circulation、The whole process supervision used，Supervise enterprises in strict accordance with national laws and regulations and quality specifications、Sales drugs，Monitoring drug adverse reactions，Timely risk reminder，Strict investigation and punishment of violations of laws and regulations，Ensure for the safety of medication。Local governments at all levels are responsible for drug safety work in their own administrative areas，Including drug safety in the government assessment and evaluation system，Establish an evaluation and evaluation and accountability system。Improve pharmaceutical supervision institutions at all levels and rural drug supervision networks，Ensure that the drug regulatory agency work independently in accordance with the law。
(5) Improve the practice pharmacist system。Cooperation with deepening the reform of the medical and health system，Formulate the implementation of the business specifications of practicing pharmacists，Strict practice pharmacist access，Promoting the continuing education project of a practicing pharmacist，Improve the overall quality of a practicing pharmacist，Promoting the development of the Pharmaceutical Pharmacist Team。Increase the use of the use of practicing pharmacists，Since 2012，New retail pharmacies must be equipped with practicing pharmacists; to the end of the "Twelfth Five -Year Plan"，All retail pharmacy legal persons or main managers must have qualifications for practicing pharmacists，All retail pharmacies and hospital pharmacies are in the operation of a practicing pharmacist to guide reasonable medication，Unable to meet the requirements，Cancellation of drug qualifications。
(6) Strengthen the organization leadership of planning implementation work。Local governments at all levels must determine the development goals and main tasks of the development of this plan，Incorporate drug safety work into important agenda and economic and social development plan for the region。Relevant departments must be divided into labor according to their responsibilities，Refined target，Default task，Establish a specific implementation plan，Do a good job of implementing related tasks。2013 mid -year and the end of 2015，The National Food and Drug Administration led the interim and final assessment of the planning and execution situation，Evaluation and assessment results report to the State Council。
