Last week, Rx-360, a pharma supply chain consortium aimed at patient safety through a secure supply chain, quietly published the white paper on Traceability Data Exchange Architecture (TDEA) (see “Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture”).
This is a new addition of major importance to the thin collection of public resources companies have available to understand the scope and the specifics of pharma serialization and traceability regulations around the world—and that’s just the first half of the document. In fact, that half is so complete and well written that it should be downloaded and read immediately by anyone facing those regulations anywhere in the world…especially if you face any of the regulations outside of the U.S. where accurate and complete information can often be very sparse. It is almost incredible that such a useful document would be publically available for free, but it is.
That first half of the document is a catalog of existing and approaching regulations in Brazil, China, United States, European Union, Turkey, South Korea and Argentina. Each section covers one of these regulations in a concise, standardized format that allows easy comparison. The standardized section headings used for each regulation include Mandate Status, Serialization, Key Dates, Supply Chain Data, Data Repository, Funding and Governance.
Most of the second half of the document is an overview of the potential data storage and choreography models, including a high-level review of the work of the GS1 Event-Based Traceability work group which earlier documented several models including central, semi-central and distributed models.
One of the conclusions of the TDEA document is this gem:
“The consensus of the TDEA workgroup participants is that industry must align on a proactive path forward to determine a deliverable, efficient data choreography model. To meet this goal in a timely manner, an industry dialog that furthers development and adoption of a broad strategy for determining an eventual model must begin very soon. Industry must collaborate on the key characteristics of an eventual model, including the distribution of the cost burden, responsibilities, risks, security considerations and reporting of information. The model should offer flexibility, allowing some important characteristics to be harmonized among existing and prospective global requirements.”
This document is well worth the time invested in reading it, and you can also sign up for their webinar to review the document. Thanks to the TDEA team and Rx-360.