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Argentina's drug safety strategy: Why do 3,000 drugs require unique serial numbers?
In the process of global drug distribution, special drug safety and security considerations are particularly important. The distribution of certain drugs requires cold chain management, and the industry often uses track and trace technology. However, differences between countries in terms of implementation time and information required make relevant laws and standards vary.
Because the government controls the entry of drugs, the distribution and supply chain management of drugs are far more stringent than for other commodities. The entire distribution process starts with the manufacturing of drugs in the pharmaceutical industry, followed by intermediaries in the public, private sector and non-governmental organizations to obtain the drugs, and finally these drugs find their way into the hands of different categories of consumers. Good Distribution Practice (GDP) is a quality assurance system that includes requirements for the procurement, receipt, storage and export of medicines for human consumption.
This system regulates the movement and segregation of drugs by different modes of transportation from the pharmaceutical factory or other central point to the end consumer, and even to points in between.
Argentina’s drug tracking program
Since 2011, Argentina has launched a national drug tracking program that lists more than 3,000 drugs that must have unique serial numbers and tamper-evident features on their secondary packaging. These drugs are recorded in real time in a central database managed by Argentina's National Agency for Medicines, Food and Medical Devices (ANMAT). The purpose of the program is to actively limit the use of illegal drugs.
This move demonstrates Argentina’s strong commitment to protecting public health and safety.
Drug tracking measures in various countries
In Brazil, Federal Law No. 11,903 passed in 2009 and the subsequent Sanitary Inspectorate (ANVISA) stipulates that all secondary packaging must be labeled with a 2D Data Matrix code. Under these regulations, manufacturers are required to maintain a database of all transaction data, while distributors are required to report serialized transaction data to the manufacturer and maintain databases of suppliers, drug recipients, and packaging companies.
In China, since 2008, the State Food and Drug Administration (CFDA) has required that more than 275 therapeutic drug products that can be sold individually must be serialized by December 2015. It should be noted that the CFDA does not follow international standards and manufacturers must submit an application to obtain the serial number of the product.
In Europe, relevant guidance on good distribution practice is based on Directive (EU) 2017/1572 of September 15, 2017. According to the 2016 False Medicines Directive (FMD), all medicines sold in the EU must have mandatory "safety features". By February 9, 2019, all pharmaceutical companies will be required to connect their internal systems to EU databases to check product authenticity.
In the United States, the Drug Supply Chain Security Act (DSCSA), passed in 2013, clarified the requirements for establishing electronic systems to identify and track distributed pharmaceuticals and required all supply chain partners to do so by November 27, 2023 Equipped with comprehensive electronic tracking capabilities.
Circulation of illegal drugs
The illicit drug trade operates differently from the circulation of legal drugs. The distribution of illicit drugs intersects with, but in many ways does not directly overlap with, the trade in various contraband.
As governments around the world strictly control drug distribution systems, drug tracking and identification have become increasingly important. This not only ensures the safety of patients' medication, but also effectively resists the circulation of illegal drugs. But in the process of implementing such a policy, how to balance drug accessibility and safety has become a question worth pondering?
