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“.
Given the globalized production and distribution of medicines, the rapid exchange of information between regulatory authorities is essential to protect the integrity of the supply chain and patient safety. Track and trace systems are therefore considered a useful tool to mitigate the risk of drug shortages and to fight against falsified medicines.
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 and supporting pharmacovigilance activities.
ICMRA developed the recommendations in consultation with the World Health Organization (WHO), representatives from international medicines regulatory authorities and experts from the private sector.