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Recently, the "Fourteenth Five-Year Plan for National Drug Safety and Promotion of High-quality Development" jointly issued by 8 departments including the State Food and Drug Administration and the National Development and Reform Commission mentioned the need to accelerate the reform of the "three-medicine linkage" and establish drug safety governance Multi-departmental collaborative policy toolbox
"The "14th Five-Year" National Drug Safety and Promotion of High-quality Development Plan"
This multi-sectoral collaborative policy toolbox, one of which is to promote the establishment of "three-medicine linkage" big data , through the "three-medicine linkage" policy coordination, support innovative products, pass generic drug quality and efficacy consistency evaluation products, and have good credit The company’s products carry out centralized procurement of medicines in accordance with regulations
Promote the establishment of "three-medicine linkage" big data to support informatization data sharing in the fields of medical care, medicine, and medical insurance, and promote the establishment of "three-medicine linkage" big data
In fact, as early as 2016, the General Office of the State Council issued the "Guiding Opinions on Promoting and Regulating the Development of the Application of Big Data in Health Care" (Guobanfa [2016] No.
It is required to eliminate data barriers, unblock data sharing channels between departments, regions, and industries, and explore social health and medical data information exchange mechanisms
, Strengthen data collection on population, public health, medical services, medical security, etc.
Through the efforts of the "14th Five-Year Plan", the data of medical care, medical insurance and medicine has gradually improved standards and information processing specifications from decentralization and fragmentation, unified data structure and improvement of data transmission and storage.
For pharmaceutical companies, a forward-looking and clear understanding is required:
1.
2.
The drug bidding procurement model of public medical institutions may gradually change from the current project invitation system to automatic price correlation and automatic matching of supply and demand
4.
Online purchases, matching transactions, reasonable use, and unified payment form a complete closed-loop management of prescription drugs.
Internet sales of the above-mentioned commodities may also gradually be connected to corresponding supervision;
6.
The so-called rationality means to enter or abandon a certain market in combination with its own resources, product structure and expectations for the future.
Attachment: The progress made by the "three medical" big data and the plan in the next 5 years
Big Data of National Health Information
At present, the national national health information platform has been put into trial operation, and 32 provincial-level platforms have been initially established.
In the next step, it will further implement relevant policies with relevant departments, and fix the data sharing and business collaboration mechanisms with railways, civil aviation, public security, transportation, industry and information, cyberspace and other departments that were formed in the prevention and control of new crown pneumonia.
Medical insurance big data
Since the establishment of the National Medical Insurance Bureau in 2018, in response to the serious problem of the fragmentation of the medical insurance information system, through the application of new technologies such as Internet +, big data, and artificial intelligence, it has promoted the construction of a unified national medical insurance information platform and promoted the construction of medical insurance informatization.
To meet the needs of the people and adapt to the reform and development of medical insurance
.
It is reported that the national unified medical security information platform includes 14 business subsystems such as public services and cross-province and remote medical management, which can effectively improve the national medical insurance standardization, intelligence and information level
.
After completion, medical security information in various regions will achieve national and provincial data concentration, improve data sharing levels, realize medical information management for the entire life cycle of individuals, and basically form an integrated application pattern of the national medical security business management system to enable public services More convenient, and further improve the modernization level of medical security governance capabilities
.
According to statistics from the Medical Insurance Bureau, from the start of construction in 2019 to the present, the main body of the national medical security information platform has been basically completed.
The national unified medical security information platform has been in Guangdong, Qinghai, Hebei and other 23 provinces and Xinjiang Production and Construction Corps.
On-line use, the overall operation is stable and efficient
.
As of July 2021, the national unified information platform has effectively covered 49,000 designated medical institutions and 71,000 designated retail pharmacies, with more than 30 million settlements in pharmacies, more than 70 million outpatient settlements, and more than 7 million inpatient settlements.
, More than 11 million settlements were made for medical treatment in different places across provinces
.
Big Data of Drug Regulatory Information
During the "14th Five-Year Plan" period, it is necessary to improve the application service level of "Internet + drug supervision"
.
Promote the integrated application of the Industrial Internet in the regulatory fields of vaccines, blood products, and special drugs
.
Establish and improve the electronic general technical documentation system for drug registration and the electronic application information system for medical device registration, and promote the digitalization and networking of review and approval and license management
.
Accelerate the promotion of mobile internet applications in the cosmetics supervision field to improve work efficiency and service levels
.
Promote the interconnection and interoperability of supervisory business systems at all levels and units, share and share supervisory information, and gradually realize "one network connection" and "cross-province operation"
.
Strengthen the application of big data in national drug supervision
.
Integrate health, medical insurance, drug supervision and other departments, as well as industry organizations, pharmaceutical companies, e-commerce platforms and other data resources to enhance the data collection, correlation and financing, risk research and judgment, and information sharing capabilities of the entire drug life cycle
.
Strengthen the coordinated services and supervision of national drug traceability
.
On the basis of urging and guiding enterprises to complete the construction of drug traceability system, priority is given to the record of traceability code coding rules and traceability information collection of vaccines, narcotic drugs, psychotropic drugs, blood products, and national-organized drugs in the centralized procurement of drugs, so as to gradually realize the entire post-marketing process Traceable
.
Improve the basic database of medicines, medical devices and cosmetics
.
Provincial-level drug regulatory agencies establish and improve basic databases of regulatory objects, cosmetics registrants (filers), and manufacturing companies in the administrative area for the production and operation of drugs and medical devices, and update them dynamically, and establish drug marketing license holders and medical services in the administrative area.
The credit record of the device registrant (filer) and the manufacturer
.