Chinese medicine drinking tablets are an important part of Chinese medicine，It can be used for use in the clinical formula of Chinese medicine，It can also be used for Chinese patent medicine production，Its quality is related to the safety and effectiveness of the people for medication。In recent years，Drug supervision departments at all levels continue to increase the supervision and inspection and sampling inspection of Chinese medicine drinks，Investigate and deal with and expose illegal illegal enterprises and unqualified products，The overall quality status of Chinese medicine drinks has improved，But the problems of existence are still not optimistic。To further strengthen the supervision and management of Chinese medicine drinks，Improve the quality of Chinese medicine drinks，The State Drug Administration decided to carry out the one -year -old Chinese medicine decoction quality centralized rectification，The specific scheme is as follows:
1. Overall target
Guided by Xi Jinping's new era of socialism with Chinese characteristics，Careful implementation of the spirit of the 19th National Congress of the Communist Party of China and the requirements of General Secretary Xi Jinping's "four strictests" on the "four strictests" of drug safety，Persevere problem -oriented、Principles of both specimens，Focus on solving the outstanding problems existing in the current Chinese medicine tablets，In -depth investigation of systemic、Regional risk hidden dangers，Strict investigation and punishment of illegal violations，Accelerate the establishment and improvement of a long -term mechanism that is in line with the characteristics of traditional Chinese medicine tablets，Improve supervision ability and level，Improve the quality of Chinese medicine drinks，Ensure for the safety and effectiveness of public medication。
2. Key work
(1) Strict investigation and punishment of illegal acts and regulations of traditional Chinese medicine drinks
1. Strict investigation and punishment of illegal acts and regulations for stake online sports bettingthe stake betting appproduction link of traditional Chinese medicine drinks。Strengthen the supervision and inspection of the production link of traditional Chinese medicine,，Key investigation and punishment of traditional Chinese medicine materials to enter the factory is not strict，Use doping to make fakes、dyeing weight gain、Mold and deteriorating Chinese medicinal materials produced Chinese medicine tablets; the production of traditional Chinese medicine drinks; the production capacity and sales are not matched，Broken production and sales records，Do not conduct inlet and exit inspection in accordance with regulations，Inspection records are not real; purchase illegal Chinese medicine drinks for replacement packaging for sale; rental lending license，Packing the production of Chinese medicine drinks to illegal acts such as illegal laws and other illegal behaviors。
2. Strict investigation and punishment of illegal acts and regulations illegal behaviors illegal behavior。Strengthen the supervision and inspection of the circulation of traditional Chinese medicine,，Key investigation and punishment provides a place for others to operate Chinese medicine drinks illegal、Qualification certificate file、Bills and other conditions; not strictly reviewing the supplier's qualifications，Or purchase Chinese medicine tablets from illegal channels and sells (or use); illegal packaging、Processing or stickers to sell outsourcing Chinese medicine tablets; illegal acts and other illegal acts such as toxic Chinese medicine tablets。
3. Strict investigation and punishment of unqualified Chinese medicine drinks。Increase the sampling inspection of traditional Chinese medicine，Improve the coverage and pertinence of the sampling inspection of Chinese medicine drinking slices in the market，Key sample sample slices of Chinese medicine mixed with fake、dyeing weight gain、Mold deterioration、Sulfur fumigation、Pesticide residues and other projects。All places should combine the actual situation of supervision in the administrative area，Formulate a spot check plan，Increase the frequency of sampling inspection for key areas and key varieties。
4. Strict investigation and punishment of illegal production and operation of Chinese medicine drinks。Resolutely ban the illegal den who is unlicensed to produce and operate Chinese medicine tablets，Strictly crack down on illegal processing such as private cutting system、Actions to produce Chinese medicine tablets in disguise，Strictly cracking down on criminals to operate Chinese medicine drinks without licensed Chinese medicine。
(2) Accelerate the improvement of the technical management system that conforms to the characteristics of Chinese medicine tablets
1. Strict admission standards for strict Chinese medicine decoction production enterprises，Strictly verify the scope of the production of Chinese medicine drinking films; revise the provincial -level traditional Chinese medicine decoction tablets stake online sports bettingin accordance with the "Provincial Traditional Chinese Medicine Drinking Film Making Revised Principles" issued by stake betting appthe State Administration。
2. Promote the formulation of standardization of traditional Chinese medicine drinking tablets; strengthen the management of new Chinese medicine registration，Develop "Principles of the Guidance of the Quality Control of Chinese Medicine Materials"，Amendment and improvement and improvement of Chinese medicine new drugs register "Principles of the Technical Guidance of Traditional Chinese Medicine Materials"; timely revision and improve the quality standards，Enhance the scientific and applicability of the standard of Chinese medicine drinks; ensure the supply of standard substances of traditional Chinese medicine，Strengthening the information management of standard material in traditional Chinese medicine，Carry out the study of digital replacement alternatives of standard substances in traditional Chinese medicine; study and explore the management system of traditional Chinese medicine beverage tablets。
3. Revised and published the quality management specifications of Chinese medicinal materials (GAP)，Study and promote the implementation of GAP filing management; study and formulate measures to encourage and guide Chinese medicine decoction companies to use GAP bases or fixed production sites to produce Chinese medicinal materials; combine the characteristics of traditional Chinese medicine decoction tablets and the current production actual actual production，Affairs and improved GMP Chinese medicine drinking tablet，Enhanced applicability，Promote the standardization of Chinese medicine drinking companies、Professional、Large -scale production。
3, schedule of progress
(1) Mobilization deployment stage (August -September 2018)
Provincial drug regulatory departments must according to the requirements of this work plan，Unified thought，Cooperative action，Combined with local actual situation，Establish a specific implementation plan for rectification work，and submit it to the National Bureau before October 12, 2018。
(2) Organization implementation stage (October 2018 -September 2019)
Provincial drug regulatory departments shall organize the quality improvement of traditional Chinese medicine drinks in accordance with this work plan and specific implementation plan。Highlight key issues，Urgent enterprises to implement the main responsibility，Resolutely investigate and deal with violations of laws and regulations; improve the working mechanism and related management system，Revised local traditional Chinese medicine decoction tablets to make specifications。
Provincial drug supervision departments must complete the summary of rectification work by the end of October 2019，Submit to the State Administration，Work summary should include inspection and sampling inspection、Discover problems and processing、Get results and work advice, etc.。
(3) Supervision and summary Stake Sports Bettingstage (September 2019)
The National Bureau organizes supervision and inspection by random Stake Sports Bettinginspections，solid work、High achievements，Units and individuals who investigate and deal with major cases，Give praise and reward; not in place for supervision、If the responsibility is not implemented or the major cases are not handled，Give criticism and order correction。All places must carefully sort out the rectification work of traditional Chinese medicine drinks，Analysis of the cause of the problem，Research solving countermeasures，Summary experience and practice，Consolidate action results，Long -term work mechanism formed by the supervision of Chinese medicine drinking tablets。
4. Work requirements
(1) Strengthen organizational leadership
Provincial drug regulatory departments must attach great importance to the rectification operation of traditional Chinese medicine drinks，Determine work focus and goals in the implementation plan of the specific rectification work。Other departments responsible for drug supervision at all levels shall actively cooperate with the provincial drug supervision department to carry out related work，Effectively strengthen organizational leadership during institutional reform，Carefully organized implementation，Strengthen funding protection，Unified Organization Organization Exclaiming Force，Carry out a targeted manner。The State Administration will track and judge the special rectification work，Guidance Supervision，Unified Regulations and Policies Execution，Uniform inspection case handling procedures and standards。
(2) Strictly performing responsibilities
Drug supervision departments at all levels should improve the targeted and effectiveness of rectification，Please find a problem、Eliminate hidden dangers、Preventing risk，Touring the origin of the clues found、Check the end。To be fair in supervision and law enforcement、Justice、Public，Resolutely prevent local protection，Resolutely eliminate the case without investigation、Light case、Punishment of punishment、Questions to be punished for punishment。Say love for enterprises in law enforcement cases、All records of interference cases are recorded in the case，and discipline according to law and discipline。
(3) Increase the investigation and punishment
Drug supervision departments at all levels discovered that the production and operation of Chinese medicine decoction pieces did not meet GMP、GSP requirements，Resolutely order to order rectification、Recovery or revoking quality management specification certification certificates and other processing measures，For the existence of serious violations of laws and regulations，Resolutely order enterprises to stop production and operation and investigate and deal with it stake online sports bettingin accordance with the law，until the "Drug Production License" or "Drug Business License"stake sports betting app，Suspected crimes，Transfer stake online sports bettingto the public security organs to investigate its criminal responsibility。All Chinese medicine drinks that are not qualified，Resolutely find out for its product sources。Products for illegal violations and unqualified inspection，Inspection and inspection results are publicly exposed in accordance with laws and regulations。Need to expose illegal and illegal Chinese medicine decoction tablets production and operation enterprises，It is also exposed to use unqualified use of Chinese medicine tablets。Treatment of illegal cases，It is necessary to punish illegal production and operation units，It is also necessary to investigate the responsibility of the person in charge directly responsible for the unit and other direct responsible persons。
(4) Strengthen coordination and cooperation
In the rectification operation，To strengthen collaboration with relevant departments，Forms a joint supervision force; give full play to the role of industry associations and experts and scholars，Guide industry self -discipline and corporate integrity; strengthen publicity，Accept the public and public opinion supervision，Create a good atmosphere of rectification。
