In the United States, the pharmaceutical and medical device industries are aware of pending regulation on unique identifications. This bit of label compliance seeks to standardize identification for drugs and medical devices to cut down on instances of counterfeit labeling.
For example, we wrote recently about the Food and Drug Administration's (FDA) guidance on physical-chemical identifiers, the small inks, dyes or lettering that pharmaceutical companies print on their medicine. In a separate post, we also touched on the FDA's unique device identification system (UDI), a database designed to increase the industry's label tracking and traceability and improve patient safety.
Well, U.S. regulators aren't the only ones looking for solutions to the challenge of counterfeit labeling. Last week, the European Union (EU) released a concept paper titled "Delegated Act on the Detailed Rules for a Unique Identifier for Medicinal Products for Human Use, and Its Verification."
The paper was released for public comment and at the urging of a directive from the European Parliament. Essentially, the EU would like to implement some sort of safety requirements to ensure the authenticity of pharmaceuticals on the market. At this point, the regulator is debating letting manufacturers have a say in safety specifications or pushing their own rules through legislation.
In addition, the paper says there are a lot of considerations to weigh, such as what goes into determining a serial number, what kind of technology manufacturers are encouraged to adopt – 2D barcodes, RFID tags, etc. – and even at which point in the supply chain these serial numbers are checked.
All told, it's an exhaustive look at the issue of counterfeit labeling and medicinal authenticity, but the EU concept paper is really only scratching the surface. Stakeholders will still have to weigh the costs and benefits of different labeling approaches, solutions and technologies, so while we're still far away from a resolution, it bears watching if you're in the EU drugs market.