EMA supports use of global Track & Trace Systems

The European Medicines Agency, EMA, supports recommendations developed by the International Coalition of Medicines Regulatory Authorities (ICMRA) to facilitate the use of global track & trace systems. The agency states that the ICMRA paper identifies "common technical denominators that allow different systems to exchange and use the available information on medicines and their supply chains in order to protect public health".

Background

According to the EMA, until now, track & trace systems have been designed and implemented with a local or regional focus, without considering whether they can share information with other systems. However, with the globalized manufacture and distribution of medicines, rapid exchange of information between regulators is essential to protect the integrity of the supply chain and patient safety. Global tracking systems are thus considered a useful tool to mitigate the risk of drug shortages and to fight against falsified medicines.

Promotion of global Track & Trace Systems

To promote a common understanding for the implementation of global tracking systems, the ICMRA paper analyzes the potential benefits of interoperability and presents detailed application examples.

The cases presented aim at illustrating areas where interoperability of traceability systems is considered to enable benefits to public health. These areas include, for example:

• Fight against falsified medicines,
• Facilitate batch recalls,
• Improve pharmacovigilance,
• Mitigate drug shortages.

In addition, the ICMRA paper describes technical features that would enable the interoperability of national / regional systems, such as the use of

• numeric product identifiers,
• widely accepted and adopted international data standards for pharmaceuticals identification, coding and data exchange (e.g. GS1),
• data elements (e.g. globally unique product code + serial number + expiry date and batch/ lot number),
• data carriers (e.g. Data Matrix Code),
• data exchange standards.

Accordingly, the prerequisite is that the authorities agree on a single international standard (or one standard per defined sector) for transactional interoperability, e.g. in cases where data carriers have to be scanned in various different system environments. In principle, the use of the data matrix code is recognized as a cost-effective solution and the use of this is affirmed in the paper. An example is given of a possible system architecture to illustrate how the principles and recommendations described in the paper can be applied in practice. It is noted that the system architecture described is only an example and does not exclude other equally valid and equivalent solutions. In addition, the document includes a useful glossary to help better inform readers who are not experts in traceability systems.

More information can be found under Interoperability of track and trace systems: key to public health protection published on the EMA website.