RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 2021 > 8 > ICMRA releases framework for aligning global track and trace systems

ICMRA releases framework for aligning global track and trace systems

Posted 09 August 2021 | By Joanne S. Eglovitch 

ICMRA releases framework for aligning global track and trace systems

The International Coalition of Medicines Regulatory Authorities (ICMRA) has issued a broad set of recommendations outlining how regulators and industry can set up track and trace systems that are globally aligned to ensure counterfeit or falsified products do not infiltrate supply chains.
The report, which was issued by a joint regulators/industry working group, explores the technical features that would allow for interoperable national and regional track and trace systems. It covers the use of product identifiers, standards, data carriers, master data and information exchange.
The report endorsed many of the principles in an earlier report, such as the use of international standards for interoperability, and the use of data matrix barcodes. (RELATED:  IMCRA Looks to Make Track-and-Trace Systems Globally Interoperable, Regulatory Focus, 11 January 2018)
The recommendations cover the process of identifying a pharmaceutical pack using a globally unique product code, the capturing of that identifier from a data carrier, and the exchange of information each time the package is moved and data captured within the system.
Endorses international standards
The report “strongly” endorses the idea that regulators use international standards such as GS1 standards governing interoperability, as well as standards from the international standards body for medical products of human origin (ISBT). The use of data matrix barcodes was also promoted as the most “cost effective solution” in planned traceability systems.
It also covers three track and trace systems, including systems which allow full traceability of product transactions from beginning to end of the supply-chain; point-of-dispense verification systems, or systems which allow verification of the product only at the beginning and at the end of its supply-chain; and systems in-between which have elements of both features.
Some of the report’s 13 recommendations include the following:
  • Use numeric identifiers on products instead of alphabetic ones. “As countries use different alphabets, the inclusion of letters within product identification can lead to interoperability issues between systems.”
  • Use “widely accepted” international standards such as GS1. “It is essential that products can be uniquely identified on a global basis which is only possible if every country follows/aligns on the specifications defined by compatible international standards.”
  • Use four data elements on products, including a globally unique products code, a serial number, expiration date and batch or lot number
  • Use a globally standardized syntax. “A globally standardized syntax issued by an approved standardization body shall be used to ensure that scanning devices know how the data is encoded and are therefore able to read the data and interpret it.”
Three data architecture models to follow
The report says authorities can use three different data architecture systems for tracking products through the supply chain: the centralized model, the semi-centralized model and the distributed model. ICMRA, however, promotes the centralized and the distributed data model. “A central database or repository is generally the most efficient and simple way of allowing traceability data from multiple parties to be reported, stored and queried. It is perfectly possible however to design a system with distributed databases where each originator stores their own data.”
These three systems were also outlined by the US Food and Drug Administration in its recent guidance on enhanced drug distribution security; the agency is leaning towards a distributed or semi-distributed data architecture model. (RELATED:  FDA details plans for DSCSA implementation in four guidances, Regulatory Focus, 4 June 2021)
The European Medicines Agency (EMA) announced on 6 May that it endorsed the report.
IMCRA paper on interoperability
EMA announcement


© 2022 Regulatory Affairs Professionals Society.