December 20, 2017
Supply Chain Integrity has been an ICMRA strategic priority since November 2015. Given the importance of Track and Trace (T&T) systems in ensuring the integrity of the medicines supply chains, ICMRA agreed that this project, at least in its initial phase, would focus on T&T systems.
T&T systems have been so far designed and implemented with a local or regional focus, and no consideration has been given to their interoperability. As production and distribution of medicines are nowadays often globalised however, the rapid exchange of regulatory information among regulatory authorities is integral to the protection of the supply chain integrity and to the protection of patient safety. T&T systems could enable such rapid exchange of information among regulatory authorities along the supply chain.
ICMRA, building on work already done by the WHO SF Member States Mechanism, collected information on existing and planned T&T systems for medicines around the world and used this information to develop recommendations on how existing and planned T&T systems should be better aligned globally, in order to allow for their interoperability. This document discusses various aspects such as the prospective advantages for public health which would arise from interoperability of T&T systems for medicines and what the challenges are to reach such interoperability. It also recommends some common technical features T&T systems should have in order to enable their interoperability and proposes next steps ICMRA might take in order to implement these recommendations. The document has been endorsed as a formal ICMRA document, and is provided below.