21 June 2023
The International Coalition of Medicines Regulatory Authorities (ICMRA) is a voluntary association of regulatory agencies who cooperate in order to overcome current global challenges and to set specifications for areas and activities, for example, which are similar for regulatory authorities worldwide. Moreover, possible synergy areas are to be identified.
Supply Chain Integrity and the associated Track & Trace (T&T) Systems were identified as an ICMRA priority in 2015. Track & trace is a topic the ICMRA wants to take charge of during the initial phase, at least. Therefore, the ICMRA has adopted recommendations on the launch of Track & Trace Systems on 25 October, 2017, so as to indicate the importance of system compatibility.
"Interoperatibility" is defined as the ability of T&T Systems to exchange information and utilise the information received by another system. Since there is no global agreement on technological recommendations, there is an increasing number of different T&T Systems, which negatively influences interoperatibility.
Differences in national and international T&T Systems increase the complexity of the worldwide tracking of products in case of a defect, a pharmacovigilance issue or a counterfeit product. It also imposes a higher load on the industry that must adapt to various national and international T&T requirements for product distribution.
The ICMRA paper's objective is to give recommendations and strategic guidelines for improving the alignment of T&T systems. As soon as the compatibility of individual T&T Systems has been achieved, other systems, such as the "Rapid Alert System" of the PIC/S member states, should also be added.
Regarding the technical aspects of T&T Systems, the ICMRA recommendations address:
Additionally, Annex 1 of the document lists 13 questions by 22 regulatory agencies. Annex 2 shows different scenarios of how information paths may proceed.
Please see the complete ICMRA "Recommendations on Alignment of Existing and Planned Track and Trace (T&T) Systems to Allow for Interoperatibility" for more information.