EMA Endorses Track-and-Trace Recommendations

The European Medicines Agency (EMA) announced on August 6, 2021 that it has endorsed the International Coalition of Medicines Regulatory Authorities (ICMRA) recommendations for global track-and-trace systems. ICMRA identifies, in a paper published by the organization, common technical denominators for systems to exchange and use drug and supply chain information. The interoperability of track-and-trace systems may help protect public health by sharing information on quality issues, drug shortages, and falsified medicines, according to the ICMRA paper, which was developed in consultation with the World Health Organization.

“Production and distribution of medicines are globalised and rapid exchange of information among regulatory authorities is integral to the protection of supply chain integrity and patient safety. Track and trace systems are considered to be a useful tool to mitigate the risk of shortages and fight production and marketing of falsified medicines. They provide visibility into the supply chain of medicines at any given time. However, until now, traceability systems have been designed and implemented with a local or regional focus, without taking into consideration whether they can exchange information with other systems at the global level,” EMA stated in a press release.