The International Coalition of Medicines Regulatory Authorities (ICMRA) published recommendations to facilitate the use of track and trace systems at global level. The 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.
«Recommendations on common technical denominators for traceability systems for medicines to allow for interoperability» (PDF, 1611 KB)
In this paper, international regulators emphasise that the interoperability of track and trace systems helps to protect public health by improving information sharing in case of quality defects, reducing shortages, contributing to the fight against falsified medicines and supporting pharmacovigilance activities. A common understanding of these potential benefits of interoperability is fundamental to promoting global planning and implementation of interoperable systems for medicines.
The ICMRA paper was open for public consultation from November 2020 to February 2021. The extensive and helpful feedback was carefully analysed and reviewed in order to refine and finalise the recommendations on common technical denominators for track and trace systems. More details on the comments received and the ICMRA analysis of these comments is available in a separate document.