Global Meds Regulators Publish Track and Trace Recommendations

Global meds regulators publish track and trace recommendations

A group of international medicines regulators has published recommendations intended to ease the use of track and trace systems, focusing on the technical aspects of sharing data between them.

The International Coalition of Medicines Regulatory Authorities (ICMRA) has prepared the document in parallel to the development of a policy paper on national traceability systems for medical products by the World Health Organization (WHO), which was published in April.

The new recommendations focus on interoperability, the common technical denominators that will allow different systems to exchange and use the information on medicines and their supply chains.

It covers identifiers of products, standards, data elements, data carriers, transitional and master data, traceability, and information exchange, as well as providing recommendations on the use of common data coding standards and common data carriers.

The paper reinforces the use of international standards like GS1 for medicinal products and ISBT 128 for blood and tissue products, and the use of datamatrix barcodes as “one of the economical solutions in use in most of the current and planned traceability systems and appears to be the most cost-effective solution.”

The main recommendations are as follows:

  1. Use numeric product identifiers;
  2. Enable the use of widely accepted international standards;
  3. Use four data elements – unique product code, serial number, expiry date and lot/batch number;
  4. Provide clear requirements on packaging level identification;
  5. Use ISO/IEC Data Matrix on secondary packaging;
  6. The use of scratch-off mechanisms is not recommended as they add costs and don’t increase security;
  7. Avoid mandating the use of RFID;
  8. Avoid mandating the use of 2D/Matrix bar code other than ISO/IEC Data Matrix on secondary packaging data carriers for product identification;
  9. Barcodes do not replace human readable information on the pack; and
  10. Use a globally standardised syntax.

The ICMRA notes that deploying 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.”


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