The International Coalition of Medicines Regulatory Authorities (ICMRA) has its eye on aligning existing and planned track and trace systems worldwide, with a focus on interoperability as many of the existing and planned systems were designed with a national or regional focus.
Track and trace systems, which have been or are currently being implemented in the US, EU, Turkey, Argentina, Canada, Italy and Japan, are used to help ensure falsified, counterfeit or otherwise unsafe medicines do not enter countries’ supply chains.
But one of the issues for pharmaceutical companies and for countries tracking falsified or otherwise illegal prescription drugs across borders is that many have different systems and requirements that must be adhered to.
For instance, an ICMRA survey of member regulators found that current track and trace systems employ 2D barcodes, linear barcodes and radio-frequency identification as a means of tracking medicines, while various systems also use both GS1 coding standards and the European Article Numbering Code. ICMRA also noted that Australia, Costa Rica, Fiji, Switzerland and Uruguay currently have no plans to implement track and trace systems.
So why should track and trace systems be interoperable? ICMRA offered a hypothetical scenario in which the systems could help countries work together to root out counterfeit or falsified medicines: "A product is produced in country A, and exported to countries X, Y and Z. Regulators from country X discover during inspection of the manufacturer that batches of the product have been produced with a counterfeited active substance. Information is input from country X in the system, and shared in real time with regulators in countries A, Y and Z. Pharmacists dispensing the affected batches to patients in countries X, Y and Z receive an alarm message when scanning the barcode."
Moving forward, ICMRA said it will look to develop more detailed guidance on common technical features for enabling interoperability, develop tools for jurisdictions wishing to implement track and trace systems, examine further technicalities on interoperability, and identify solutions related to obstacles in exchanging information between the different systems, like questions over data ownership and confidentiality.
"By establishing a common language among the supply chain regulatory and industry actors, it directly supports the identification and management of risks associated with counterfeit or substandard health products and enables enhanced pharmacovigilance. It can also contribute to further mutual reliance in risk-based decision-making as it increases certainty about the health product and the industry party at stake in particular health and safety risk situations (e.g. facilitation of recalls, detecting fraud, monitoring internet sales)," ICMRA said.
INTERNATIONAL COALITION OF MEDICINES REGULATORY AUTHORITIES (ICMRA) SUPPLY-CHAIN INTEGRITY PROJECT