The International Coalition of Medicines Regulatory Authorities (ICMRA) seeks to align existing and planned track and trace systems globally, thus promoting interoperability across national borders. In this way the agency intends to develop greater coherence among the numerous systems currently in use (and in development), which are 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 prevent falsified, counterfeit or otherwise unsafe medicines from entering countries’ supply chains. These many systems and requirements in place in different countries constitute an obstacle for pharmaceutical companies and countries trying to track falsified or otherwise illegal prescription drugs across borders.

For instance, an ICMRA survey 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.

The importance of interoperability

Articulated systems could help countries work together to identify and combat counterfeit or falsified medicines. It would simplify the exchange of information, which could then be shared in real time with regulators in other countries. If this were the case, pharmacists dispensing the affected batches to patients in different countries could receive an alarm message when scanning the products’ barcodes.

ICMRA said it will look into several lines of work to this end, such as.

• developing more detailed guidance on common technical features so as to enable interoperability,
• developing tools for jurisdictions wishing to implement track and trace systems,
• examining further technicalities on interoperability, and
• identifying solutions related to obstacles in exchanging information between the different systems, like questions over data ownership and confidentiality.

The standardization of information systems would directly support the identification and management of risks associated with counterfeit or substandard products. This could enable 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.

ICMRA supply-chain integrity project

The ICMRA document on Recommendations on Alignment of Existing and Planned Track and Trace (T&T) Systems to Allow for Interoperability is available here.