The European Union carried out the standardization of drug traceability earlier, and its established legal and regulatory system and supporting organization and implementation agencies are currently the most complete and complete in the world. This article will systematically introduce the construction of the EU drug traceability system and its present, let's learn about it.
development process

In February 2006, the European Federation of Pharmaceutical Industry Associations (EFPIA), in conjunction with various stakeholder groups in the pharmaceutical supply chain, set out to establish a European-wide electronic drug regulatory system, the European Drug Verification System (EMVS).

Based on the concept of cost-benefit maximization, EMVS selects the internationally common two-dimensional matrix code as its information carrier, adopts the operation method of "dispensing point verification", and is jointly managed by all stakeholders in the drug supply system (Figure 1).

Figure 1 Operation diagram of the EU prescription drug tracking and traceability system.

In September 2008, the European Union established a special EMVS system steering committee. The committee is composed of EFPIA, the European Pharmacy Union (PGEU) and the European Union of Pharmaceutical Wholesale Companies (GIRP) as full members, the European Federation of generic drug manufacturers (EGA) as an observer, and four institutions. Each agency represents the interests of original research drugmakers, pharmacies, drug wholesalers and generic drugmakers, and jointly guides and makes decisions on the implementation of EMVS.

The relatively balanced institutional setup effectively balances the interests of the major groups and is conducive to the active implementation of the drug electronic regulatory system. In addition, under the guidance and assistance of the EMVS System Steering Committee, the EU will also establish the European Medicines Validation Organization (EMVO). The main task of the organization is to establish and manage the European Drug Coding Centre. The European Drug Coding Centre is the data transmission portal for drug manufacturers and parallel importers, through which all drug manufacturers and parallel importers in the EU upload or verify drug information on a unified way, which is connected to several national systems or national blueprint systems (see Figure 2).

Figure 2 Implementing bodies of the European system for electronic regulation of medicines

In July 2011, the European Parliament and the Council of the European Union passed the "EU Counterfeit Drug Directive", which clearly requires the establishment of a safety file "for verifying the authenticity" of every drug in circulation in the EU, and the establishment of a common EU country The database stores drug safety information. The enactment of the Act lays the legal foundation for the implementation of the European system of electronic regulation of medicines.

The European drug electronic supervision system uses the "two-dimensional matrix code" to assign codes to individual drugs, adopts the "dispensing point verification" mode, and realizes the safety supervision and flow tracing of drugs by enforcing the verification of pre-drug supervision code information. After years of operation, the model has been widely recognized in European countries, and has basically achieved full coverage in all countries.

principle and application

Drug manufacturers must print the two-dimensional matrix code for storing drug information on the secondary packaging of each box of drugs before the drugs leave the factory, that is, on the packaging components that are in direct contact with the drugs. According to the European Drug Packaging Coding Guide, the two-dimensional matrix code structure must comply with GS1 standards and contain the following drug information: the global trade item code (GTIN) of the drug, the drug serial number, the drug expiration date and the drug batch. Among them, the drug serial number is an important identification of the electronic regulatory system to identify the drug, the requirements are not repeated. In addition, in order to prevent counterfeiters from calculating the serial number of the drug according to the law, the generation process is completely random, and the serial number can only be reused after the drug has exceeded the shelf life of 7 years. After the coding is completed, the manufacturer needs to scan the barcode to complete the correlation between the drug and the serial number, and send the coding information to the European Drug Coding Center database.

Other participants in the pharmaceutical supply chain (such as wholesalers), after obtaining system approval, can voluntarily issue a verification request at any time by scanning the two-dimensional matrix code on the pharmaceutical packaging to confirm the pharmaceutical information. In addition, the EMVS Steering Committee plans to establish a drug tracking system in the second phase of the EMVS system operation, with drug distributors adding relevant information through the existing data exchange network.

Figure 3 Schematic diagram of operation mode of European drug verification system

Drug sellers, mainly hospital pharmacies and retail pharmacies, play a very important role in the traceability system. According to the Information Transmission Requirements for the Implementation Phase of the European Drug Verification System, pharmacists must scan the two-dimensional matrix code on the drug packaging before selling the drug. After the scan is completed, the system compares the detected drug information with the information in the central database. If the information scanned in the matrix code matches the information in the database and other criteria are met (such as "drug in shelf life" and "drug not in recall"), the pharmacist can release the drug to the patient and the drug status in the database is automatically changed to "released". If the information scanned into the matrix code does not match the information in the database (e. g. "the serial number does not exist in the database" is displayed), or the drug status represented by the serial number is "sold", then the drug may be counterfeit. At this time, the pharmacist should refuse to sell the drug to the patient. After that, the system automatically sends a counterfeit alert to the manufacturer of the drug. The operation mode of the European drug verification system is shown in Figure 3.