Looking back on 2021｜Drug supervision modernization has taken more solid steps

In 2021, the government service platform of the State Food and Drug Administration and the version 2.
0 of the National Drug Intelligence Supervision Platform will be launched, and the informatization guarantee of medical device supervision will be further strengthened.
The level of "drug supervision" has been greatly improved, and the modernization of drug supervision has taken more solid steps
.

"Internet + government services" continue to improve

"Internet + government services" continue to improve

In recent years, the State Food and Drug Administration has further promoted "Internet + government services", laying the foundation for the realization of "all-in-one service" for drug regulatory administrative services
.

The online service hall of the government service platform of the State Food and Drug Administration (hereinafter referred to as the online service hall) has completed the connection with various government service business systems, and all major businesses have been handled online

In December 2021, the Drug Electronic General Technical Documentation Management System (eCTD) of the Drug Evaluation Center of the State Food and Drug Administration was put into trial operation.
The application for marketing authorization of the same category can be reported online through the electronic general technical document of the drug, which is an important step in the electronic declaration of drug registration
.

The Electronic Registration Information System (eRPS) and the new technical review system for medical device registration were launched in 2019.
The Medical Device Technical Review Center of the State Food and Drug Administration took the lead in promoting the electronic application of the whole process, and the efficiency of medical device registration and application was greatly improved
.

In 2021, the Information Center of the State Food and Drug Administration (hereinafter referred to as the Information Center) and the China Academy of Food and Drug Control will jointly build a cosmetic registration and filing information service platform
.

The platform integrates the registration and filing of cosmetics and new cosmetic raw materials, realizes the unified management of basic information of enterprises, and connects with the online service hall and the national drug intelligence supervision platform, so as to facilitate the one-stop login and one-stop operation of cosmetics enterprises

Not only that, in order to further optimize the "Internet + government services", the State Food and Drug Administration has also actively deepened the application of electronic licenses
.

The information center shall build an electronic license management system in accordance with the unified requirements of the national integrated online government service platform, and promote the sharing and mutual recognition of electronic licenses across departments and regions

Iterative upgrade of drug smart supervision platform

Iterative upgrade of drug smart supervision platform

With the rapid development of new Internet technologies and the deep integration of "Internet + drug supervision", the drug supervision system has carried out many beneficial explorations in the field of smart supervision, promoting the continuous updating and iteration of the information system construction in the field of drug supervision
.

According to the staff of the E-Government Office of the Information Center, since the State Food and Drug Administration issued the "Action Plan on Accelerating the Promotion of Smart Drug Supervision" in May 2019, the drug regulatory department has actively promoted the construction of the smart drug supervision system and achieved fruitful results
.

Among them, the National Drug Intelligence Supervision Platform Version 1.

In 2021, the State Food and Drug Administration will promote the iterative upgrade of version 2.
0 of the National Drug Intelligence Supervision Platform in an orderly manner
.

Version 2.

The information center continuously integrates the regulatory business system to form a "big system": the business application system covers drug approval and record-keeping and information collection functional modules, and completes 13 drug approval and record-keeping modules such as domestic production drug registration, overseas production drug registration, and drug production.
Construction of 12 information collection business modules including license management; take the lead in promoting the integrated construction of medical device review and approval, and carry out the integration of local power-related systems; realize the registration and filing of cosmetics and new cosmetic raw materials on one platform; build a comprehensive business management platform , to promote the integration and co-construction of comprehensive businesses such as foreign affairs, assessment, government information submission, and veteran cadre services
.

Through the integration and docking of the above four sections, the unified login portal is convenient to supervise the use of users

In addition, in order to implement the requirements of "promoting the digital management of the whole life cycle" in the "Implementation Opinions on Comprehensively Strengthening the Construction of Drug Supervision Capacity", the State Food and Drug Administration continued to make efforts to gather, manage and apply big data, and promote the deployment of drug variety files, Establishment of drug safety credit files, formulate management regulations, clarify the boundaries of responsibilities, and consolidate the responsibilities of all parties
.

The version 2.

Local smart supervision practice blossoms

Local smart supervision practice blossoms

Smart drug supervision is inseparable from the active promotion of local drug regulatory authorities
.

Under the unified deployment of the State Food and Drug Administration, the provincial (autonomous regions and municipalities) drug administrations vigorously promote the informatization construction of "smart drug administration", and use informatization to promote the scientific and modernization of the drug regulatory system and regulatory capacity

As the first batch of provinces (autonomous regions and municipalities) to access the 2.
0 version of the National Drug Smart Supervision Platform, Zhejiang Provincial Drug Administration, supported by digitalization, comprehensively carried out the construction of "digital drug supervision", and actively explored new models and new tools for drug safety smart supervision.
, a new method to promote the intelligent supervision of drug production; the Ningxia drug intelligent supervision platform displays the data of sampling inspection, supervision and inspection, case handling, and sunshine pharmacy management in the province in a visual way, and queries the database of Chinese herbal medicines with local characteristics, etc.
It is open to the whole country; Tianjin, on the basis of building a unified cloud platform and data center, automatically interacts with the data center of the State Food and Drug Administration through the local data center to improve the supervision efficiency
.

At the 2021 Drug Digital Intelligence Development Conference, the relevant practices of the first batch of "lighted up" provinces (autonomous regions and municipalities) in the platform version 2.
0 were also selected into 19 typical cases of smart supervision announced by the Information Center
.
Among them, the Jiangxi Provincial Drug Network Transaction Supervision System focuses on the monitoring of e-commerce business behavior, and leverages the advantages of big data technology to realize all-round perception of online sales behavior and identification of violations, forming a network covering "two products and one machine" products.
The unified supervision system of the main body; the Chongqing Drug Intelligence Supervision Platform highlights data sharing and business collaboration, establishes an approval and supervision linkage mechanism, and at the same time highlights the data fusion and intelligence connection, which enhances the application efficiency of smart supervision and informatization results, and provides a powerful force for drug supervision in the city.
intelligent platform support
.

The prefecture-level market supervision bureaus also have the courage to explore, make breakthroughs and innovations, and continue to carry out smart supervision explorations based on practical needs to improve their ability to perform their duties in drug supervision
.
The "digital makeup identification" supervision system for online cosmetics in Taizhou, Zhejiang, and the "one store, one code" smart supervision system in Jining, Shandong, etc.
, provide new solutions and explore new paths for building a new pattern of drug safety and social co-governance
.

In addition, the drug administrations of provinces (autonomous regions and municipalities) are constantly exploring the construction of electronic licenses and epidemic monitoring "sentry points" and "early warning radars", and leveraging "Internet +" to comprehensively improve the efficiency of drug supervision
.