EMA Endorses Recommendations for Track-and-Trace Systems

The European Medicines Agency (EMA) has endorsed the International Coalition of Medicines Regulatory Authorities’ (ICMRA) recommendations to facilitate the use of track-and-trace systems at the global level. The ICMRA, a voluntary, executive-level entity of medicines regulatory authorities, published a paper to identify common technical denominators to allow different systems to exchange information on drugs and their supply chains for the interoperability of track-and-trace systems.

The ICMRA paper emphasizes that the interoperability of track-and-trace systems helps to improve information sharing in case of quality defects, reduce shortages, protects against falsified medicines, and supports pharmacovigilance activities.

The ICMRA paper was open for public consultation from November 2020 to February 2021. The feedback was analyzed and reviewed in order to refine and finalize the recommendations on common technical denominators for track-and-trace systems. The ICMRA developed the recommendations in consultation with the World Health Organization, representatives from international medicines regulatory authorities, and experts from the private sector.

US moves forward with interoperability requirements

Separately, in the US, the bio/pharma industry, its supply-chain partners, and the US Food and Drug Administration are moving forward to meet a November 2023 deadline, under the Drug Supply Chain Security Act (DSCSA), which requires manufacturers to set up electronic systems to track their products through the supply chain. Phased in over a 10-year period, which began in 2013, the DSCSA outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the US. The traceability requirements in effect under DSCSA from 2015 to 2023 generally require products to be traceable at the lot level. A second phase of requirements, to go into effect November 27, 2023, require the interoperable, electronic tracing of products at the package level. In June (June 2021), the FDA issued two final and two draft guidance documents to specify recommendations for how to comply with applicable DSCSA requirements, including those for enhanced drug-distribution security at the package level that go into effect in November 2023.

One draft guidance provides recommendations on the system attributes necessary for enabling the secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation, as necessary. The FDA is requesting feedback on this guidance by early September (September 2021).

Source: European Medicines Agency


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