China Times | The chaos in COVID-19 nucleic acid testing is frequent, and the National Medical Products Administration has issued the 'strictest supervision order'

Recently, there have been frequent violations of regulations by nucleic acid testing institutions. In response, the National Medical Products Administration has taken strong action to implement responsibilities, and the nucleic acid testing industry has faced 'the strictest supervision'.

On June 7, the official website of the National Medical Products Administration issued the 'Notice on Further Strengthening the Quality and Safety Supervision of COVID-19 Detection Reagents' (hereinafter referred to as the 'Notice'). The Notice requires that drug regulatory authorities at all levels continuously strengthen quality supervision during the product development phase for COVID-19 detection reagents, strictly implement the main responsibilities of enterprises and users, and strictly enforce local government supervision responsibilities. Registrants of COVID-19 detection reagents must effectively strengthen quality management throughout the entire life cycle of their products and legally assume responsibility for the safety and effectiveness of the products during the entire process of research, production, operation, and use.

Before the COVID-19 pandemic, in the in vitro diagnostic (IVD) market, molecular diagnostics related to COVID-19 nucleic acid testing did not occupy a large market share. It was not until 2020 that the market for nucleic acid testing expanded. According to Tianyancha, in just 2021 alone, there were 437 new medical laboratory-related institutions added.

An insider from a third-party peer institution in Beijing told the Huaxia Times, "The PCR technology used for COVID-19 nucleic acid testing has been outsourced by third-party medical laboratories and genetic testing companies for a long time, and was once operated as a marginal project with low throughput."

As the COVID-19 black swan rages on, the nucleic acid testing market has expanded rapidly in the past two years. At the beginning of August 2020, according to the Ministry of Industry and Information Technology, as of the end of July 2020, China's daily nucleic acid testing capacity had reached 4.84 million samples, with 4,946 medical institutions capable of conducting nucleic acid testing and more than 38,000 technical personnel involved in testing.

On May 13, 2022, Guo Yanhong, an inspector from the Medical Administration Bureau of the National Health Commission, stated at a press conference of the State Council's Joint Prevention and Control Mechanism that there are 13,100 medical and health institutions nationwide capable of conducting nucleic acid testing. The country has 153,000 professional technicians engaged in nucleic acid testing technology work, and the nucleic acid testing capacity can now reach 57 million tests per day per tube.

In comparison, in less than two years, the number of medical institutions in China capable of conducting nucleic acid testing has increased by nearly 160%. In response, the aforementioned individuals stated, 'In the IVD industry, nucleic acid testing mainly utilizes molecular biology methods and belongs to the subfield of molecular diagnostics. This field is not the mainstream market in the testing industry, with a relatively small demand. The segments that account for a higher proportion in the IVD track include biochemical diagnosis, immunodiagnosis, blood cell testing, and other sub-markets.'

In response to changes in market demand, companies within the industry have quickly made adjustments. However, both enterprises and capital are driven by profit-seeking motives. Therefore, behind the rapid growth, various chaotic phenomena have emerged.

It has been reported that multiple third-party testing institutions in Beijing, Hebei, Henan, Anhui, and other places have falsely reported results and been placed under investigation for suspected criminal offenses. The suspects have been taken into compulsory measures. Among these cases, there are many instances where testing institutions are suspected of violating the Law on the Prevention and Control of Infectious Diseases, with most violations involving the forgery of test results. Just taking Beijing as an example, in May 2022, three cases were exposed: artificially diluting samples to affect the accuracy of test results, which is suspected of constituting a crime against the prevention and control of infectious diseases.

"The demand for nucleic acid testing has increased, requiring more operators and occupying machines. In this situation, enterprises can only find ways to compress costs. Third-party institutions operate on a self-financing basis, and it is difficult to rely solely on corporate self-discipline under the premise of profit-making. This requires higher-level units to strengthen supervision and professional units to assist in supervision, thereby promoting third-party institutions to conscientiously and responsibly complete nucleic acid testing tasks. Nowadays, with large-scale and regular nucleic acid testing, enterprises need to bear significant labor and financial costs, which even affect the expansion of other businesses, but the income is minimal," the aforementioned person further revealed.

On May 21st, the Beijing Fangshan District Government website updated administrative penalty information, showing that due to the original test data being significantly less than the number of samples tested, Pushe Medical was revoked its 'Medical Institution Practice License' by the Fangshan District Health Commission. On June 6th, the Fangshan Branch of the Beijing Public Security Bureau charged seven suspects including Zhou Moumou and Wu Moumou with the crime of obstructing the prevention and control of infectious diseases, and requested the approval of the Beijing Fangshan District People's Procuratorate for their arrest. After examination, the procuratorial organs made an arrest approval decision against Zhou Moumou, Wu Moumou, and the other six individuals on suspicion of obstructing the prevention and control of infectious diseases according to the law.

On the afternoon of May 27th, Pan Xuhong, Deputy Director of the Beijing Public Security Bureau, reported that since April 25th this year, 'Beijing Jinzhun Medical Laboratory Co., Ltd.' has been illegally conducting tests on nucleic acid samples collected from multiple districts using multi-tube mixing methods. They artificially diluted the samples, affecting the accuracy of the test results and are suspected of violating the crime of obstructing the prevention and control of infectious diseases. Wang Moumou (male, 43 years old), the legal representative of the laboratory, and 16 others were arrested, and the case is under further investigation.

On May 28th, according to the WeChat account of 'Safe Beijing', it was discovered that 'Beijing Zhongtong Lanbo Medical Laboratory' was suspected of illegal and criminal activities during nucleic acid testing. Currently, the Beijing police have filed a case against the laboratory for investigation, apprehending the legal representative Zhang Moumou and others, and the case is under further work.

Against this backdrop, on June 7th, the General Administration of Drug Supervision and Administration of China issued the 'Notice on Further Strengthening the Quality and Safety Supervision of COVID-19 Detection Reagents'. The 'Notice' proposes to implement 'the strictest supervision' for COVID-19 detection reagents, taking resolute and effective measures. It strictly enforces the main responsibilities of enterprises and users, as well as the local supervision responsibilities of local governments. Vigorous and meticulous supervision work will be carried out without relaxation, firmly holding the bottom line of quality and safety, consolidating hard-won supervision achievements, and providing strong support for epidemic prevention and control.

Specifically, the 'Notice' proposes 'four strictest' measures and 'three major requirements'. Drug regulatory authorities at all levels should earnestly implement supervision and inspections, and delve deeply into and investigate issues and clues discovered in supervision sampling, complaints and reports, online monitoring, risk consultations, etc. For illegal and irregular activities such as unlicensed production and operation, improper storage and transportation, or the use of unregistered or expired COVID-19 test kits, they should be dealt with strictly, swiftly, and according to law. If suspected of constituting a crime, they should be promptly transferred to the public security organs. Supervisors suspected of dereliction of duty should be promptly transferred to the discipline inspection and supervision organs.

The 'Notice' specifies that provincial drug regulatory authorities should, in accordance with the requirements of previous work, maintain regular supervision. They should continue to organize professional forces to conduct supervision and inspections on registrants of COVID-19 test reagents and their entrusted manufacturers within their jurisdictions. The authorities should supervise enterprises to strictly organize production in accordance with regulations, specifications, standards, and the technical requirements of registered products, ensuring that the quality management system remains compliant. Special attention should be paid to inspecting the source of product raw materials, standardization of production processes, product quality control, release from factory and market, adverse event monitoring, product quality analysis and evaluation, etc. If serious violations are found in production activities that cannot ensure product safety and effectiveness, the enterprise should be ordered to immediately suspend production, recall problematic products, and carry out effective disposal. In cases where the violation is particularly serious, the medical device production license should be revoked according to the law, and relevant responsible persons should be punished according to the law.

Drug regulatory authorities at all levels should continue to strengthen the quality supervision and random inspection of COVID-19 testing reagents. For COVID-19 testing reagent products produced by registrants and entrusted manufacturers within their jurisdiction, full coverage random inspections should be carried out in accordance with the special sampling plans formulated by the national bureau. For products that fail the supervision and random inspection, drug regulatory authorities should immediately take corresponding disposal measures, ordering the enterprise to suspend production, analyze the reasons for non-compliance and carry out rectification. Production can only resume after being re-inspected and found compliant by provincial-level drug regulatory authorities.

The municipal and county drug regulatory departments should, in accordance with their responsibilities, effectively strengthen the supervision of product quality and safety during the use of nucleic acid testing reagents for COVID-19. They should carefully inspect whether the product qualifications, procurement channels, expiration dates, etc., of nucleic acid testing reagents used by medical institutions (including third-party medical laboratories) meet the requirements and whether the quality is qualified. If any illegal or non-compliant activities are found, they should be promptly reported to the relevant departments.

*This article is reprinted from 'Huaxia Times', authored by Guo Yilin, with the original title 'The Scattered Phenomena of COVID-19 Nucleic Acid Testing: The National Medical Products Administration Issues the 'Strictest Supervision Order''.