On May 11, 2022, the State Drug Administration (SDA) issued the "14th Five-Year Plan for Drug Regulatory Network Security and Informatization Construction" (hereinafter referred to as the "Plan"), which specifies the objectives of drug regulatory network security and informatization construction during the "14th Five-Year Plan" period, (hereinafter referred to as the "Plan"), which specifies the construction objectives, key tasks and safeguard measures of drug regulatory network security and informatization construction during the "14th Five-Year Plan" period.

The Plan states：

Looking forward to the "14th Five-Year Plan" and the vision of 2035, China is going to realize the leapfrog development from a big pharmaceutical country to a strong pharmaceutical country, which puts forward higher requirements for the efficiency of drug review and approval and the ability of drug safety risk management. At present, there are still many deficiencies in the construction of drug regulatory information technology, the integration and innovation of information technology and regulatory business needs to be enhanced, data-driven and knowledge service capabilities need to be upgraded, the integrated construction and operation and management of information resources need to be optimized, and network and information security still need to be further strengthened.

The Plan sets out the construction goals of a better "big platform" support, a smarter "big data" drive and a more comprehensive "big system" application.

The Plan specifies that by the end of the 14th Five Year Plan period, with the goal of supporting drug safety and high-quality development, a comprehensive framework for intelligent drug supervision technology will be established; Implementing the requirements of the "streamlining administration, delegating powers, and improving services" reform, optimizing the business environment, and realizing all government service matters "It will also promote the digital management of the entire life cycle of medicines, improve variety files, establish safety credit files, and improve the level of accurate supervision based on big data;

In addition, it will improve the drug informatization traceability system and realize the traceability of key varieties of drugs; promote the linkage application of the unique identification of medical devices in the fields of medical care, medical insurance and pharmaceuticals; strengthen the integration of the informatization application of cosmetic regulatory business and the construction of mobility; promote the digitalization and intelligent transformation and upgrading of the drug industry; build a social co-governance system for drug regulation, and enhance the public's participation in drug safety, so as to make people more satisfied with the quality and safety of drugs and give them more peace of mind. quality and safety, so that the people will be more satisfied and more assured with the quality and safety of medicines.

The Plan sets out five key tasks:

1. Upgrade the "two products and one device" intelligent supervision capability;

2. Enhancement of the capacity of integrated government services;

3. Promote regulatory data fusion and drive;

4. Building a digital base for intelligent drug regulation;

5. Strengthen the comprehensive network security capacity.

At the same time, the Plan breaks down the sixteen key tasks in columnar form:

1. Capacity-building for drug regulation;

2. Capacity building for the regulation of medical devices;

3. Cosmetic regulatory capacity building;

4. Informationized traceability system construction;

5. Improve the national adverse drug reaction monitoring system;

6. Supervise the construction of information technology support capacity for the management of specialized teams;

7. Capacity building for mobility of regulatory business systems;

8. Project for upgrading the capacity of government services;

9. Construction of a nationally integrated pharmaceutical intelligence supervision platform;

10. Improve the construction of national and provincial data centers;

11. Further improve the "two products and one device" variety of files;

12 Create a drug safety credit file;

13. Building a sound system of standards and norms;

14. Upgrade the pharmacovigilance cloud resource pool;

15. Improve the network security and trust system;

16. Improvement of the Security Management Operation and Maintenance Center.

Among other things, in the area of capacity-building for drug regulation

The Plan proposes to take the supervision of the quality of the vaccine production process as a breakthrough, and, on the basis of the electronic production and inspection data of vaccine production enterprises, to explore the digital management of the quality of vaccine production, the quality risk early warning and emergency response mechanism through the study of the data of the key links in vaccine production, so as to enhance the effectiveness of drug supervision and the ability to manage risks.

Capacity building in medical device regulation

The Plan proposes to strengthen the application of digital supervision of medical devices, fully implement the electronic management of medical device review and approval by the State Bureau, and build a medical device review and approval system covering acceptance, registration, continuation, change and approval.

Capacity-building in cosmetics regulation

The Plan proposes to continue to build and improve the registration of new raw materials for cosmetics and toiletries, filing, cosmetic quality and safety sampling, registration and filing inspection, monitoring of adverse reactions, on-site verification, flight inspection and management of standardization and revision of business systems and functions, based on a unified application support system, to achieve integration and sharing and business synergies, and to enhance the ability of cosmetics mobile office and regulatory services. Promote the issuance of electronic certificates for cosmetic registration certificates.

Informatization traceability system construction

The Plan proposes that the State Administration continue to strengthen the operation and management of the vaccine traceability collaborative service platform and the national vaccine traceability supervision system, and on this basis, promote the construction of the drug informatization traceability system, establish a sound drug traceability system, expand the construction of the drug traceability collaborative service platform and the traceability supervision system, and gradually realize the supervision and control of the traceability of key varieties, such as narcotic drugs, psychotropic drugs, blood products, and the varieties selected by the State Organization for Centralized Purchasing. Traceability supervision of varieties.

Aspects of creating a drug safety credit profile

The Plan proposes that, in accordance with the unified planning and deployment of the State, and taking into account the actual situation of the pharmaceutical industry, the construction of drug safety credit files for holders of marketing authorizations for pharmaceutical products (manufacturing enterprises) should be accelerated, and relevant information on drug safety risks and credit should be collected, including drug production authorizations, results of daily supervision and inspection, investigation and handling of illegal acts, random inspection and testing of pharmaceutical products, records of undesirable behaviors, and complaints and reports, and published and timely updated to the society in accordance with the law and regulations. It shall publish and update such information to the society in accordance with the law.

As of now (May 2024) the Regulation has been published for two years and guidelines have been issued across the country:

Shandong to speed up the "intelligent drug supervision" integrated application, informationization traceability system construction, building a solid drug safety bottom line

Source:Lu.com Time February 29, 2024

Shandong Provincial Drug Administration to consolidate and improve drug safety action as a grasp, continue to deepen the "safety enhancement" project, solidly carry out "drug safety and responsibility" "remove the risk of clearing up" and "Leak sword to punish bad" "strong foundation to enhance the ability" and other special actions to build a firm bottom line of drug safety in all aspects. "Leak sword to punish the bad" "strong base to enhance the ability" and other special actions, all-round building a strong drug safety bottom line, with a high level of safety escort high-quality development.

Vigorously implement credit supervision and intelligent supervision, accelerate the integrated application of "intelligent drug supervision" and the construction of informatization traceability system, and lead the modernization of supervision with informationization. Strictly implement the "Opinions on Promoting the Construction of the Provincial Drug Safety Grid Management System", and open up the "last kilometer" of supervision. Promote the standardization of drug supervision capacity in cities and counties, and regularly organize inspector skills competitions, inspection competitions, case handling competitions and other "big competition" activities to comprehensively enhance the regulatory capacity.

Ningxia Drug Administration establishes and improves the quality control mechanism for the use of drugs in medical institutions

Source: Ningxia Hui Autonomous Region Drug Administration Time: March 5th

In accordance with the current drug regulatory laws and regulations, the Drug Administration of Ningxia Hui Autonomous Region has revised the "Code for Quality Management of Drug Use in Medical Institutions of Ningxia Hui Autonomous Region (Trial)" (hereinafter referred to as the Code), which has expired on a trial basis, in order to establish and improve the mechanism for monitoring the quality of drug use in medical institutions, to further strengthen the management of the quality of drug use in medical institutions across the region, to enhance the level of quality management of drug use in medical institutions, and to standardize the behavior of drug use. Drug use behavior.

The revised Code focuses on four aspects to regulate the use of drugs in medical institutions. First, it is clear that medical institutions should establish and improve the quality management system of drugs, improve the quality management system of drugs purchase, acceptance, storage, maintenance and use of the links, and clarify the post responsibilities of staff in each link. Secondly, it is clear that medical institutions should set up a specialized department responsible for drug quality management, and if there is no specialized department, it should designate a person responsible for drug quality management. Third, it is clear that medical institutions should actively assist the holders of listed drug licenses, manufacturers of traditional Chinese medicine tablets and drug wholesalers in fulfilling their obligations of drug recall and recovery. Fourth, it is clear that medical institutions should establish a whole-process traceability system covering the purchase, storage and use of medicines, carry out the verification and collection of traceability data, and provide traceability information of medicines in accordance with the regulations.

The revised Norms require regulatory authorities at all levels to determine a certain percentage of medical institutions each year, based on the quality management of medicines in medical institutions, the use of varieties and the risk and credit situation of drug safety such as inspections, inspections, complaints, reports, etc., to inspect the management of medicines in their purchase, acceptance and storage, and inspect all the medical institutions in the administrative area within three years.

State Drug Administration issued the quality management standard for medical device business July 1, 2024 onwards

Source: people.com   Time: December 7, 2023

According to the website of the State Drug Administration (SDA), in order to regulate the operation of medical devices and promote the standardized development of the industry, the SDA revised and issued the "Code of Practice for the Management of Quality in the Operation of Medical Devices" (hereinafter referred to as the "Code"), which will come into force on July 1, 2024, and the former "Announcement on the Enforcement of the Code of Practice for the Management of Quality in the Operation of Medical Devices" by the State Food and Drug Administration (No. 58 of 2014) will be simultaneously is repealed at the same time.

The relevant person in charge of the State Drug Administration introduced that since its release and implementation in 2014, the Code has played a positive role in regulating the business behavior of medical devices, strengthening the quality supervision of medical device business, promoting the standardized development of the industry, and safeguarding the safety and effectiveness of public use of devices. In recent years, the medical device industry has been developing rapidly, and the number of medical device business enterprises in the country at the end of November 2023 was nearly three times that of the same period in 2014. At the same time, new policies such as centralized band purchasing of high-value medical consumables and the unique marking system for medical devices have been introduced; and new business models such as Internet sales, third-party logistics, and supply chain management of medical consumables have been emerging.

The main content of the revision of the Code: First, the 2014 version of the Code in the enterprise management and regulatory practice there are difficulties in the implementation and understanding of the ambiguity of the provisions of the suitability of the revision, in order to make the content of the norms more in line with the quality of the medical device business chain management and supervision of the actual situation.

Secondly, the new regulatory elements are identified and supplemented to adapt to the new regulatory approach. Clarify the requirements of the unique identification of medical devices in product acceptance, out of storage review, computer system, clarify that electronic certificates and paper certificates have the same legal effect, and encourage enterprises to use information technology to transfer and store electronic certificate information.

Thirdly, it is to identify the new forms and new business modes that have emerged and to supplement the blind spots of quality management in the business process. For example, new quality management of vending machines, management of multi-warehouse collaboration, quality management of direct transfer, and management of products sold after clinical confirmation.

Ningxia promotes the construction of informatization traceability system for Chinese medicine tablets production enterprises

Source: Ningxia Drug Administration   Time: December 7, 2012

Ningxia Drug Administration recently issued the "Ningxia Hui Autonomous Region Chinese medicine tablets production enterprise informationization traceability system construction guidelines", on the Ningxia Chinese medicine tablets production enterprise informationization traceability system construction, to promote the high-quality development of the traditional Chinese medicine industry and other arrangements and deployment.

The Guiding Principles make it clear that the main parties responsible for the quality and safety of medicines have the obligation of traceability, and that they should carry out electronic registration, management and querying of key information, so as to build a traceability chain for the whole process of production, circulation and use of Chinese herbal medicinal tablets that is traceable in terms of origin, verifiable in terms of destination, and accountable in terms of responsibility.

In accordance with the relevant arrangements of the Guiding Principles, the varieties that will be implemented in Ningxia by the end of June 2024 for informatization and traceability include: varieties of traditional Chinese medicine tablets produced by using freshly cut Chinese herbal medicines in the place of production while they are freshly cut (including varieties of catalogs issued by foreign provinces and regions), Chinese wolfberries as well as varieties of traditional Chinese medicine tablets produced by using poisonous Chinese herbal medicines.

The Guiding Principles make it clear that uniform standards and specifications should be adopted in promoting the construction of the traceability system, and that data interoperability between the traceability system of Chinese herbal medicinal tablets manufacturers and the drug traceability module of the Ningxia Drug Wisdom Supervision Platform should be realized through unified modules, data collection formats and contents, interface specifications, etc., and that the data of drug traceability data should be guaranteed to be true, accurate, complete, tamper-proof and traceable. The retention period of drug traceability data records and vouchers should be not less than five years, and at least until one year after the expiration date of the drugs.

The Guiding Principles also specifies specific information technology requirements for the construction of the traceability system in terms of standards, functions, links, personnel and safety, etc. It emphasizes that the traceability system of Chinese medicine tablets producers should include the functions of collecting, storing and sharing information on the traceability of Chinese medicine tablets in the whole process of production, circulation and use, to ensure that the whole process of the source, concoctions and sales of Chinese medicine tablets can be traced, and comply with the data exchange technical standards formulated by the State Administration of Pharmaceutical Control. Data exchange technical standards.

Jilin Provincial Bureau of Pharmaceutical Supervision clarifies key points of drug safety supervision in 2024

Source: China Jilin Time: April 1, 2024

Jilin Provincial Bureau of Pharmaceutical Supervision issued "2024 Annual Drug Safety Supervision Work Points" (hereinafter referred to as "Work Points"). There are 26 articles in the Work Points, which put forward eight key tasks: comprehensively investigating and resolving risks and hidden dangers, strengthening supervision in key areas, deepening the consolidation and improvement of drug safety, promoting the high-quality development of pharmaceutical and health industries, enhancing the level of drug supervision and administration in accordance with the law, building a regional authoritative inspection and testing institutions, enhancing the level of modernization of drug supervision, and promoting the overall governance of the Party.

The Work Points emphasize that we should promote the standardized construction of drug supervision capacity in cities and counties, vigorously develop drug safety township coordinators and village information officer teams, and strengthen the grass-roots foundation of drug safety governance; promote the action plan of regulatory science, and build regulatory science bases; enhance the level of drug supervision informationization, deepen the application of "Smart Drug Supervision (Phase I)", and establish "Jilin Province Biologics Issue Digital Platform"; accelerate the construction of "full-time inspectors + part-time inspectors" drug inspection system, and vigorously cultivate national inspectors; strengthen the integrity system. In addition, we have established a digital platform for the issuance of biological products in Jilin Province, accelerated the construction of the drug inspection system of "full-time inspectors + part-time inspectors", and vigorously cultivated national inspectors, strengthened the construction of the integrity system, and pushed forward the construction of the credit file of drug safety for holders of listed drug licenses, and established the provincial bureau of drug safety management. Credit file construction work, the establishment of the provincial bureau of medical device credit file and medical device species file construction work leading group to promote the "two files" construction.