The Reference Significance of Drug Traceability System in the United States and the European Union to China


Release time:

2016-04-07


Recently, the State Food and Drug Administration publicly solicited opinions on the "Drug Business Quality Management Regulations" (revised draft), intending to adjust the drug electronic supervision system to a drug traceability system, and cancel the mandatory requirements for electronic supervision code scanning and data uploading. Among them, whether it is the one thing and one code of the United States or the "safety file" of the European Union, it provides a reference for my country to improve the drug traceability system.
The announcement also said that the suspension of the implementation of the relevant provisions of the electronic supervision of drugs. This is the first time that the general office of the State Council issued the opinions on accelerating the construction of traceability system for important products in January this year, which clearly proposed to promote the construction of traceability system for seven categories of important products, such as special equipment, and for the first time, the ministries and commissions systematically proposed a programmatic document to promote the construction of traceability system.
In this case, China's relevant departments issued a policy, requiring coding docking unified, reduce the burden of equipment identification and business operations is imperative. In fact, the current development of important commodity traceability systems in various countries in the world is also uneven, especially the drug traceability system. There are some common problems, but it is relatively successful in the United States and the European Union.
United States: one thing a yard The experience of the United States is that they enacted the "Prescription Drug Marketing Act" in 1988, which requires the implementation of records on the source and sales of drugs. In order to prevent falsification of records, the FDA (U.S. Food and Drug Administration) has decided to adopt radio frequency identification technology RFID(Radio Frequency Identification). Borrowing RFID, the rapid reading and writing of electronic tags is realized, and the mobile identification of targets is also realized, which ensures the tracking of the whole process of drug production and circulation.
In 2011, FDA further promoted the implementation of standardized digital identification, ensuring that one thing, one code, and printed on drug packaging in the form of bar codes. In this way, layer-by-layer verification is ensured, and the transparency of drugs in the entire supply chain is greatly improved. After drug problems are discovered, reverse logistics can be performed by collecting drug location and holder information, so that drug recalls and other tasks Become faster and easier.
EU: Establishment of a security dossier
In 2008, the European Union began to enforce the verification of pre-drug regulatory code information to realize the safety supervision and flow traceability system of drugs. In September 2008, the European Parliament and the Council of the European Union adopted the "dispensing point verification" model, by balancing the interests of the European Federation of Pharmaceutical Industry Associations, the European Pharmacy Alliance, the European Union of Pharmaceutical Wholesale Enterprises, and the European Union of Generic Drug Manufacturers. Pre-drug regulatory code information verification to realize the safety supervision of drugs and a system for tracing the flow of drugs.
In 2011, the EU Anti-counterfeiting Drug Directive was adopted within Europe, which clearly requires the establishment of a security file "that can verify its authenticity" for every drug circulating in the EU, and the establishment of a database that is common in EU countries. After the implementation of this model, in addition to the national capital investment, only manufacturers and retailers need to invest in the implementation of the system, the circulation enterprises do not need to invest. In view of this, the effect of this mode is very significant.
Although our neighboring country Japan does not have a special drug traceability system, it has a mature food traceability system. Relying on such a traceability system, their drug traceability process is also very clear.
China: many aspects need to be improved
In short, from foreign experience, it can be seen that professional regulatory agencies and teams, modern information technology, strict laws and system construction are the three cornerstones of the traceability system. For us, the completion of efficient and convenient drug traceability will not happen overnight.
First of all, the unified standard is the premise, is the core of the construction of traceability system. In this way, through the collection and recording of product production, circulation, consumption and other links of information, the source can be traced, the destination can be traced, and the responsibility can be investigated. But to achieve this, it is possible to gradually improve the drug traceability system on the basis of the law after perfect legislation and related management systems.
Secondly, the information platform is the key to complete the traceability system. The promotion and application of information technologies such as the Internet of Things, big data, cloud computing, and mobile Internet provide a technical foundation and guarantee for the establishment of a modern traceability system. In the United States, the European Union and other places, the traceability system has been improved, which is related to the early development of its information platform, the rapid development, and the rational application of related technologies; on the other hand, in China, there are still many problems in the construction of information platform, which can not keep up with the development needs, and play a very limited role in the traceability system.
Finally, strict accountability is a strong guarantee for this work. This means to ensure that violations are prosecuted. This requires the establishment and improvement of law enforcement regulatory agencies and teams, dare to enforce the law, and be stricter than law enforcement. No matter which company or enterprise violates the relevant system, it must cancel its qualification and shall not engage in business in this field for a few years. In order to form a deterrent to illegal enterprises.
At present, China's drug-related codes include electronic supervision codes, commodity bar codes, drug standard codes, drug classification codes and logistics bar codes, etc. The drug information carried by these codes is not only duplicated, but also incompatible with each other, bringing repeatability and poor traceability to the identification of equipment and business operations. From the experience of various countries, in order to improve China's drug traceability system, we should learn from other mountains and gradually improve the relevant work on the basis of understanding our own problems.