Electronic regulatory buildup number gradually expanded to all listed drugs

According to the regulations of the State Food and Drug Administration, any successful bidder who produces a variety of essential drugs must join the electronic drug regulatory network before March 31, 2011. Prior to the release of the essential drug, the manufacturer must comply with regulations. Print (paste) uniform electronic identification code for drugs on the minimum sales package of the listed products. To this end, local regulatory agencies and basic drug manufacturers are actively implementing the deployment of national bureaus.

Measures and progress

According to the unified deployment of the State Bureau, the food and drug regulatory authorities throughout the country have taken active actions to vigorously promote the electronic supervision of essential drugs. Beijing, Yunnan, Fujian, Jiangxi, and Guangdong have also taken the initiative to require demonstration projects.

The Beijing Municipal Bureau of Food and Drugs proposed to take the lead in completing the electronic supervision of essential medicines before the end of this year, setting an example for the provinces and cities. The sub-bureaus of various districts and counties in Beijing responded positively and adopted effective actions in accordance with the actual conditions in their own jurisdictions. Feng Dian, deputy director of Chongwen Branch, told reporters that the electronic monitoring of essential medicines is very tight. They feel that they are under pressure. The higher authorities require this task to be completed as a political task. They are also determined to complete the scheduled tasks on time. For this reason, they actively communicate with companies and do their best to provide services for enterprises. On August 23, the personnel of the Tongrentang Pharmaceutical Factory, which they organized within their jurisdiction, went to Beijing Bamboo Bio-Pharmaceutical Co., Ltd. (hereinafter referred to as "Zhuzhu Pharmaceutical") to visit the electronic drug surveillance system. The bio-products produced by Bamboo Biopharma were incorporated into the pharmaceutical electronic regulatory system in 2008, and the relevant operational procedures have matured. The personnel of Tongrentang Pharmaceutical Factory said that they benefited greatly from this visit and laid the foundation for the implementation of the electronic monitoring system for essential medicines.

The Changping Branch of the Beijing Municipal Bureau of Food and Drug Administration has organized several persons in charge of basic pharmaceutical production enterprises within the jurisdiction to conduct informal discussions and actively build a platform for mutual exchanges between enterprises so that enterprises can discuss the experience gained during the implementation process and the difficulties encountered, and jointly promote electronics. Regulatory work. The Changping branch requires all enterprises to clearly implement the organization and responsibilities for the electronic supervision of all types of essential drugs, and requires the legal representative to take overall responsibility for the electronic supervision of essential drugs. The quality-authorized person is fully responsible for the implementation of electronic supervision and requires the holder of a national essential drug list. Companies that have approval numbers within the scope but do not produce and apply for a while and do not implement electronic supervision temporarily will submit a written commitment not to produce or participate in bidding for essential drugs. The Bureau also requires that the basic drug manufacturer establish a contact person to report and communicate electronic surveillance related work.

Just like Beijing, the Food and Drug Administration of Hubei Province is also determined to complete the network entry of basic drug manufacturers before the end of this year. The bureau has formulated the “Progress Schedule for the Supervision of Essential Medicines and Electronics in Hubei Province”, requiring all basic pharmaceutical manufacturers in the province to join the drug electronic regulatory network before December 25 of this year. To this end, the Bureau decomposes and refines its work tasks, clarifies the leaders and coordinators of each work, breaks down the tasks at each level, and implements responsibilities at various levels. In mid-August, the Bureau held a training class for electronic supervision of basic drug manufacturers across the province to provide comprehensive training for basic drug manufacturers across the province. In October, the Bureau will hold electronic monitoring work site meetings in Wuhan and Yichang. The next step will be to intensify supervision and supervision, and will give a briefing on the progress of electronic supervision every two weeks. At the same time, the Bureau also requested the basic drug distribution companies in the province to join and use the drug electronic regulatory network as soon as possible.

In August this year, the Anhui Food and Drug Administration held a training course on electronic monitoring of essential medicines for drug manufacturers, production line business operations and software system maintenance personnel for basic drug production enterprises in the province, chiefs of safety supervision departments of various city bureaus and relevant offices of provincial bureaus. A total of more than 200 staff members participated in the training.

The Jiangxi Provincial Food and Drug Administration actively carried out electronic supervision and training for essential drugs. 105 basic drug manufacturers, 192 drug wholesalers, and about 400 people participated in the training. The Bureau has also established a system of regular inspections. Every two months, it conducts a round of inspections and inspections on the progress of local work to ensure that this work is completed on time. At the same time, the Bureau set up model companies in production and business enterprises, and organized basic pharmaceutical production and management companies to demonstrate and exchange ideas. The Bureau stipulates that before January 31, 2011, production and operation companies must complete the test run of the transformation of the packaging line, drug code, nuclear injection and verification, and data submission. In February 2011, each district/city office conducted self-inspection of the work within its jurisdiction. In March 2011, the provincial bureau will check and accept the work of each district and city office.

It is understood that 31 provinces (autonomous regions, municipalities directly under the Central Government) have completed the basic drug e-regulatory training. As of the end of August this year, 2,820 essential drug manufacturers across the country have received training and trained 5,513 enterprise personnel. At present, relevant work in all provinces (autonomous regions and municipalities) is proceeding in an orderly manner.

Research and preparation

After the State Bureau made arrangements for the electronic supervision of essential medicines, local pharmaceutical manufacturers responded positively and carried out research, preparation and implementation under the organization of local food and drug regulatory agencies.

Zhao Xianhong, Director of the Technology Quality Department of Beijing Tongrentang Group, said that the basic medicines produced by Tong Ren Tang Group now have more than 40 varieties and more than 100 dosage forms. The Group attaches great importance to the electronic supervision of essential medicines and requires subordinate enterprises with basic pharmaceutical production to formulate their respective requirements. Work plan and unified deployment.

Zhao Xianhong said that since Tong Ren Tang Group is a manufacturer of traditional Chinese medicines, the degree of automation is lower than that of manufacturers of chemical drugs. The electronic supervision of basic medicines is a promotion for the organization and management of production activities, which can prompt Tong Ren Tang Group to accelerate production automation. This is a good thing.

Shijiazhuang Fourth Pharmaceutical Co., Ltd. established an electronic monitoring code project team consisting of information center, equipment department, technical department, warehousing service department, and production department, and organized a project team to visit the pharmaceutical companies that have implemented drug electronic monitoring codes. , and then determine the work program, at present, ongoing hardware and software research and bidding.

Bayer Health Care Co., Ltd. is one of the four pilot companies established by the Beijing Municipal Bureau of Food and Drug Administration. In late September this year, the company has completed the integration of the first set of electronic surveillance code-encoding systems, and is now undergoing a "stress test." . Shen Jie, the senior quality system supervisor of the Quality Control Department of the company, introduced that the so-called “stress test” is to simulate various abnormal conditions that may occur after the actual production at the highest speed that the production line can reach to test whether the system can be timely. The correct response and processing will be made. If the test is successfully passed, production will begin officially at the end of this month. At the same time, the second system is also being installed.

Shen Jie said that the implementation of drug electronic supervision will help companies track, trace and counterfeit their own products, and contain counterfeit products. In addition, the string of goods is also a common headache for pharmaceutical companies, and the implementation of drug and electronic regulatory measures can effectively eliminate string goods, which is to make enterprises happy.

Beijing Novartis Pharmaceutical Co., Ltd. produced a total of four basic drug types. At present, there is no plan to participate in the bidding and procurement of essential drugs. However, the company still decided to implement electronic supervision. Wang Sheyi, director of the company's quality department, said that although it is not currently involved in bidding, in the long run, electronic regulation of drugs is a development trend.

Wang Sheyi told the reporter that Novartis Pharmaceutical Company has a variety of drugs that are often counterfeited by criminals. In the past, once suspicious drugs were found in various places, they were always sent to the company by mail and the inspection was slow and inefficient. After the implementation of electronic supervision, relevant enterprises and regulatory authorities in various places can quickly identify the authenticity through the electronic monitoring code, which greatly improves the counterfeiting efficiency of counterfeit drugs and makes the manufacturers of counterfeit goods innocuous.

The Novartis Group has manufacturing facilities in many countries, and many countries have already implemented drug electronic supervision. Therefore, Novartis Group headquarters has a unified implementation of standards and technical solutions. This time, they are to implement drug electronic supervision in accordance with the unified standards of the Group, and the relevant software and hardware must be imported from abroad.

For the benefits of electronic supervision to pharmaceutical companies, Kunming Pharmaceutical Group has a deep understanding. In 2008, the company joined the national special drug electronic regulatory network to implement the code management of the 5 varieties of Chinese medicine injections produced by the two varieties. The person in charge of the company said that electronic supervision can track the whole process of production and circulation of pharmaceuticals. Enterprises can query the flow of each box, each box, and each batch of medicines in real time, grasp all the information of the entire sales network, and effectively improve the company’s The management level has strengthened the supervision of the company's own sales area and promoted the informationization process of the company. In addition, the implementation of electronic monitoring code, Kunming Pharmaceutical Group canceled the original sales channel identification code, to achieve more than one yard, each circulation can quickly query the source of drugs to prevent counterfeiting and safeguard their own interests.

Experience and difficulties

For most basic drug manufacturers, electronic surveillance is undoubtedly a new topic. The process of implementing this work is actually a process of continuous exploration and summarization. In this process, some companies have obtained certain experience. At the same time, some companies are facing difficulties.

Liu Zhiqin, deputy general manager of Beijing Boran Pharmaceutical Co., Ltd., said that they have 8 varieties (of which 3 are in production) have applied for the drug electronic monitoring code, and have been sent to printers to print cartridges, integration of the coding system is also positive processing. He suggested that the basic pharmaceutical manufacturers that haven’t started yet would not wait and see, otherwise the time would be too tight. In addition, he also proposed that it would be best to apply for drug supervision codes first, hand them over to printers for printing, and then select integrators, which would improve efficiency. If you wait until you have selected the integrator and then apply for the supervision code, and then go to print, it may delay the overall operation of the system, because a large number of printing businesses require a longer period.

Bayer HealthCare Co., Ltd. has completed the integration of a set of coding systems and has gained some valuable experience.

Bayer HealthCare uses a high-speed production line with 450 boxes per minute. Because the speed is too fast, one-level codes are associated with secondary codes, and scan codes cannot be used to identify one-level codes. Therefore, they adopt the technology of camera recognition. The production line automatically bundles 10 small boxes into one unit, one unit. Taking a picture once, this not only solves the speed problem, but also automatically archives the image. Once a problem occurs, it can be traced. This is not achieved by the scanning identification method. Shen Jie, the senior quality system supervisor of the company's quality control and quality assurance department, said that with the use of photo identification technology, the cost of each production line is 70,000 yuan more. However, the advantages of camera recognition technology are not only that it can meet high-speed production, but also that it is easy to upgrade. At present, many countries use two-dimensional codes in the electronic regulation of pharmaceuticals, while China currently uses one-dimensional codes. In the future, once you need to upgrade to a two-dimensional code, manufacturers that use scanning identification technology must be replaced with a camera recognition technology because scanning technology can only identify one-dimensional codes and cannot identify two-dimensional codes. Enterprises that use camera recognition technology do not need to replace them. equipment. Therefore, he suggested that qualified companies can consider using camera identification technology in one step.

Compared with the above-mentioned companies that have gained experience, more companies are still in the phase of exploration and face some difficulties.

According to a person in charge of a pharmaceutical factory in Beijing, their basic pharmaceutical product specifications are very small, the output is large, and the profits are meager. After the implementation of electronic surveillance, the cost of labeling is increased because each minimum package has to be tagged with a supervision code. For example, he said: "Like chlorpheniramine, the cost of a bottle of medicine plus the label of the supervision code is 0.16 yuan, and the bidding price of each bottle of medicine is exactly 0.16 yuan, and the profit is zero."

Zhao Xianhong, head of the technology and quality department of Beijing Tongrentang Group, said that the biggest difficulty at present is the tightness of time. The company has many types of essential drugs, many dosage forms, and many manual packaging, and drug electronic supervision involves the transformation of the packaging line and many other links. The time is tight and difficult. In addition, the company originally had a production command system, and now it implements electronic supervision. The interface between the two systems must be well-matched and matched. This also presents a great difficulty. If it is not handled properly, it may result in the formation of production capacity. bottleneck.

In addition, many companies feel that they lack understanding of the situation of integrators and do not know how to make choices. Companies generally hope that government agencies can give more support in terms of technology.

The reporter learned that electronic supervision has brought tremendous business opportunities to integrators, and many integrators have been fighting this market. However, integrators have been mixed, causing some pharmaceutical companies to suffer losses. A drug company adopts a company's coding system. After purchasing the product, it has no longer received any support from the manufacturer. As a result, the software has a problem or find another company to solve it. In view of this situation, Xie Zhaohui, president of Beijing Aichuang, said that integrators should not only focus on the immediate interests, but also communicate regularly with customers, provide training to customers, and do their best to collect customer needs and promote product upgrading. In addition, a four-dimensional service system such as localization service, remote response mechanism, contingency planning scheme, and customer engineer training mode should also be set up.

Zhu Guofu, director of the Information Office of the State Bureau of Nationalities, said that the State Bureau is studying the issue of how to label the medicines with small packages and low prices, and will give their opinions as soon as possible.

Sun Xianze, director of the Department of Drug Safety Supervision of the State Bureau, emphasized that the electronic supervision of essential drugs is the top priority for drug safety supervision this year, and that the full electronic surveillance of the species will be implemented by the end of March next year, and it is now counting down.

It is understood that the next step will be to do a good job of the construction of demonstration sites. The State Administration has initially selected some provinces with a good foundation for electronic supervision as demonstration sites, and will hold on-site meetings at appropriate times to promote successful experiences. At the same time, the State Bureau will also provide technical support and services. The State Bureau Information Office will work with relevant units to further improve the electronic monitoring system platform, coordinate and resolve system compatibility issues, and further improve service work. Problems encountered. (Author: Zhang Jianguo)

Related Links: Pharmaceutical Electronic Regulatory Steps

first step:

In August 2007, the State Bureau issued the "Notice on the Establishment of a Special Drug Surveillance and Information Network nationwide", requiring fixed-point manufacturing companies to implement all narcotic drugs and the first class of psychoactive drugs manufactured and delivered from November 1, 2007. Formulations and small-package raw material drugs are coded with supervisory codes, and data collection and submission are conducted through special drug networks. As of October 1, 2007, fixed-point operating companies have conducted surveillance code scans of the narcotic drugs and the first type of psychoactive drug preparations and small-package raw material drugs they operate, and have collected and submitted data through special drug networks. The first step involves 18 production companies and 560 wholesale companies.

The second step:

On May 8, 2008, the National Bureau issued the Implementation Plan for Pharmaceutical Electronic Supervision, which stipulates that since November 1, 2008, electronic regulation of blood products, vaccines, Chinese medicine injections and second-class psychoactive drugs has not been implemented. If the network and the unlicensed electronic surveillance code are used together, they must not be sold. The second step involves 568 production companies and 13,000 wholesale companies.

third step:

On May 11th, 2010, the State Bureau issued the "Circular on Electronic Surveillance of Essential Medicines for All Variety" (National Food and Drug Supervision Office [2010] No. 194), stating clearly that any successful bidder who produces essential medicines should Before March 31, 2011, it joined the drug electronic regulatory network. Prior to leaving the essential drug product, the manufacturer must add (paste) the uniformly labeled drug electronic monitoring code to the minimum sales package of the listed product according to regulations and conduct data collection through the regulatory network. And submitting; Any enterprise that operates a variety of essential medicines shall collect and submit supervision code information in accordance with regulations. According to statistics, there are 307 basic medicines involving approximately 3,567 manufacturers (76% of all manufacturing enterprises). In one-step and two-step work, 13 basic drug types have been electronically supervised.

the fourth step:

On the basis of the first three steps, the National Bureau will gradually implement electronic supervision of all listed drugs.