Drug regulatory authorities to build a new crown vaccine drug regulatory safety line of defense

Read Time:10 Minute, 53 Second

Recently, China’s epidemic prevention and control of the new ten optimal measures, the new coronavirus antigen detection application program has been introduced, which on the quality and safety of vaccines, drugs and new coronavirus antigen detection reagents, etc., have put forward new requirements. In response, the State Drug Administration quickly took measures to respond to the intensive introduction of relevant policy documents, from the production and supply to the circulation and use of all aspects of strengthening supervision to ensure that the entire chain of vaccines, drugs and testing reagents and other quality and safety measures can be put into practice. At the same time, the local drug regulatory departments also acted quickly, closely cooperating with the central work plan, effectively fulfilling their regulatory responsibilities, doing their duty to guard the land and do their best to strengthen the quality supervision of anti-epidemic drugs and instruments, guiding quality and supply, severely punishing illegal acts, fully serving the overall situation of epidemic prevention and control, and creating a safe and secure environment for the public to consume drugs and medical devices.

Full coverage of the production enterprises to carry out sampling

After the introduction of the new coronavirus antigen test application program, China has increased the production capacity of relevant enterprises to protect the rapidly growing market demand. 12 December, by the State Drug Administration review, approved the Zhengzhou Antu Biological Engineering Co. So far, the State Drug Administration has approved 42 new coronavirus antigen detection reagent products.

December 13, the State Drug Administration held a video scheduling meeting to strengthen the quality and safety supervision of new coronavirus antigen test reagents, to strengthen the implementation of the main responsibility of the registrant and the implementation of local supervision responsibilities, to ensure the quality and safety of new coronavirus antigen test reagents.

According to the State Drug Administration requirements, the new coronavirus antigen test reagent registrants, manufacturing and business enterprises to fully implement the “supervision and management of medical devices regulations” and its supporting rules and regulations requirements, adhere to the problem-oriented, strengthen the bottom line thinking, focus on quality and safety risks and hazards, benchmarking quality management system requirements, comprehensive investigation and rectification.

The meeting required that the registrant as the first person responsible for product quality and safety, to strictly enforce the requirements of the production quality management norms, shall not be separated from the quality management system for production, shall not change or increase the production address, shall not be released from the factory and listing of substandard products, shall not arbitrarily modify the product labeling and instructions. Business enterprises to strictly implement the requirements of the business quality management standards, shall not be separated from the business quality management system to operate, shall not be unlicensed or unqualified to engage in business activities, shall not operate or import products that do not meet the legal requirements, shall not purchase products from illegal channels, shall not change the business premises and warehouse address, shall not be illegal transport or storage products, shall not be illegal to carry out network sales activities; network Third-party platform for trading services shall not provide illegal or illegal network trading platform services.

The new crown virus antigen detection reagent registrant, entrusted manufacturing enterprises, operating enterprises, network trading services third-party platform, to seriously investigate whether the full implementation of the main responsibility to ensure that the implementation of responsibility in place, the system in place, risk prevention and control in place, quality management in place.

Reporters noted that the video dispatch will also emphasize that drug regulatory departments at all levels to strengthen the quality management system inspection, the organization of professional forces under the jurisdiction of the new crown virus antigen detection reagent registrant and its entrusted manufacturing enterprises, network trading services third-party platform to carry out supervision and inspection. Found that there are violations, can not guarantee the safety and effectiveness of the product, to order companies to immediately suspend production, recall the product and effective disposal; serious violations, to revoke the medical device production license according to law, and the relevant responsible persons shall be punished according to law. To continue to strengthen the quality of the new coronavirus antigen detection reagents supervision and sampling, the registrant within the jurisdiction, entrusted with the production of new coronavirus detection reagents produced by the manufacturer to carry out full coverage sampling.

For the supervision and sampling of unqualified products, to immediately take disposal measures, ordering companies to suspend production, analysis to find the cause and carry out rectification, without the provincial drug regulatory authorities to review and retest qualified, shall not resume production. Supervision and inspection, supervision and sampling, complaints and reports, network monitoring, risk conferencing and other issues and clues found in the work, to dig deeper and more detailed investigation, an investigation to the end. All kinds of violations of the law, according to the law to investigate and punish strictly and seriously from the fast. Suspected of crime, to be promptly transferred to the public security organs. Supervisors and other public officials suspected of dereliction of duty, to be promptly transferred to the discipline inspection and supervision organs.

The whole process to strengthen the supervision of vaccine safety

In addition to strengthening the main responsibility of the registrant to improve the quality of the new coronavirus antigen detection reagents, the State Drug Administration also from the following four aspects to strengthen the quality and safety supervision of new coronavirus vaccines and therapeutic drugs.

First, to strengthen the supervision of vaccines, the State Drug Administration requires local drug regulatory departments to strengthen the supervision and inspection of relevant enterprises in the production process, to compact the main responsibility of enterprises, to urge enterprises to establish and effectively run the quality management system, standardize the relevant units of vaccine storage, transport management, to ensure that the whole process meets the requirements. Strengthen the capacity building of vaccine inspection and testing, do the monitoring and evaluation of suspected abnormal reactions to vaccination according to their duties, and actively cooperate with the investigation and diagnosis work. Special emphasis is placed on the quality supervision of the recently approved vaccines incorporated into the emergency use of the new coronavirus to do a good job.

Second, strengthen the regulation of new crown treatment drugs. Here is mainly for Azulfidine tablets and other new crown therapeutic drugs, strengthen supervision and inspection and product sampling, and urge enterprises to continue to comply with the production, strict change research management, strictly in accordance with the approved prescription and process organization production.

Combined with China’s unique treatment experience in the fight against the new crown epidemic, the State Drug Administration also specifically emphasized the need to strengthen the supervision of new crown treatment Chinese medicine drugs. For the masses highly concerned about the “three drug quadrilateral”, included in the “new coronavirus pneumonia treatment plan (trial version of the ninth)” and the local new crown pneumonia treatment plan of proprietary Chinese medicine, Chinese medicine tablets and Chinese medicine formula granules, combined with the characteristics of Chinese medicine varieties, targeted to strengthen supervision.

The reporter also learned that the recent State Drug Administration has accelerated the deployment of the current stage of the work of Chinese medicine drugs, specifically organized to strengthen the whole chain of Chinese medicine supervision of the special meeting, condensed a series of policy measures. These policy measures focus on strengthening the quality management of Chinese herbal materials, enhancing the regulatory effectiveness of Chinese herbal drinks, optimizing the management of Chinese medicine preparations in medical institutions, scientific management of Chinese medicine standards, innovation and improvement of the review and approval mechanism of Chinese medicine, emphasis on post-marketing evaluation of Chinese medicine, and strengthening the quality and safety supervision of Chinese medicine.

Third, the importance of strengthening the supervision of the circulation of vaccines and therapeutic drugs. The State Drug Administration requires local drug regulatory departments to urge enterprises to strictly comply with the quality management standards for drug business, especially focus on the key varieties of business channels, and urge enterprises to make sure that the accounts are clear, storage standards, and operational compliance; urge retail enterprises to strengthen the management of purchase channels and pharmacy services, and implement the requirements for the sale of prescription drugs by prescription; urge third-party platforms for online sales of drugs and online sales enterprises to implement the main responsibility .

Fourth, to prevent the flow of related products into illegal channels. Provincial Drug Administration to supervise the holder to establish an information-based traceability system to achieve the relevant drugs, vaccines sources can be traced, the destination can be traced. Clinical trial sponsors or applicants, clinical trial institutions and drug testing organizations to strengthen their own management, to prevent the test or test drugs into illegal channels.

On December 8, the State Drug Administration (SDA) organized a video conference to deploy efforts to strengthen the quality and safety supervision of new coronavirus vaccines and therapeutic drugs. Huang Guo, a member of the party group and deputy director of the State Drug Administration, stressed the need to pay great attention to the risks and hazards associated with new production starts, resumption and expansion of production, and resolutely prevent the emergence of drug quality and safety problems; to seriously analyze the special nature of the current sharp increase in drug market demand, strengthen the monitoring and research of the entire supply chain and online and offline, and crack down on illegal production and business practices to create a safe and secure drug for the public consumption environment.

Local drug regulatory departments to the front-line supervision

Local drug regulatory departments, in accordance with the unified deployment of the State Drug Administration, combined with local realities, took practical measures to strictly regulate quality and serve supply security, fully demonstrating the responsibility of local grassroots drug regulatory departments in fighting against epidemics.

The Beijing Municipal Bureau of Drug Administration has explored and established the “five-in-one” supervision model of factory-based supervision, inspection, GMP compliance inspection, risk study and early intervention, and accompanying services in the practice of NPV vaccine supervision, and has made every effort to urge enterprises to establish a sound vaccine quality and safety management system. As the recent demand for NIV antigen testing reagents from Beijing citizens has increased significantly, the Beijing Municipal Bureau of Drug Administration has provided precise assistance to six NIV antigen testing reagents manufacturers in the city and guided them to expand their production in an orderly manner, so that the daily output of reagents has been steadily increased and has now reached more than 5.3 million servings, effectively guaranteeing the market supply in the capital. On the other hand, we continue to increase supervision and organize experienced professionals to implement factory supervision to ensure that enterprises fully implement the “Regulations on Supervision and Administration of Medical Devices” and its supporting rules and regulations, and strictly enforce the requirements of production quality management norms to achieve quality and quantity assurance and supply.

Hebei is a major province in the production of epidemic prevention drugs, and a number of recommended drugs in the new pneumonia treatment program involve manufacturers in the province. In the face of heavy regulatory tasks, the Hebei Provincial Drug Administration will be the focus of supervision of the new pneumonia diagnosis and treatment program involving the preparation varieties and their manufacturers, the development of targeted inspection program, the implementation of “one enterprise, one policy, one product, one file” precision management. At the same time, it pays close attention to changes in market demand, penetrates into the production line of epidemic prevention and control pharmaceutical enterprises, grasps the production dynamics in a timely manner, increases sampling and inspection efforts, closely monitors product quality, and focuses on strengthening the quality supervision of epidemic prevention and control of Chinese medicine tablets.

The Zhejiang Provincial Drug Administration fully utilizes intelligent supervision means, relying on the whole chain of vaccine traceability supervision system “Zhejiang Miao Chain” to build a “one supervision” system with vertical connection, horizontal coordination and multi-linkage, and carries out special supervision from procurement channels, facilities and equipment, storage temperature, cold chain Transport and other aspects of special supervision.

Fujian Provincial Drug Administration of the province’s new coronavirus antigen detection reagent manufacturers to conduct collective interviews, urging manufacturers to strictly fulfill the main responsibility for product quality, requiring them to strictly control product quality and safety, and regularly carry out risk self-examination to effectively prevent the risk of hidden dangers.

Hubei Provincial Market Supervision Bureau and Hubei Provincial Drug Administration set up a task force led by the main person in charge to implement a daily monitoring and reporting system on the production, sales and prices of anti-epidemic drugs and antigen detection reagents in the province. The seven provincial pharmaceutical wholesale enterprises are required to increase the procurement and supply of 40 key species in urgent need of the market to protect the needs of medical institutions and pharmacies in Hubei Province.