Brazil: The Anvisa 2019 Pilot Report

Earlier this month Anvisa published an initial report on their drug traceability pilot as required by law there (see “Brazil Gets Rational With Their New Pharma Traceability Law” and “Brazil Publishes RDC-157 To Regulate 2017 3-Lot Pilot”).  I finally had time to use Google Translate on that report.  Google keeps improving their translation software and it is now to the point where I think the translation of this document is pretty good.  I still don’t recommend you use it for compliance decisions, but it’s great for getting a preview of what the document—originally in Portuguese—says.

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DSCSA: Historic Change To Commerce

Back in 2010 I posted an RxTrace essay called “California Pedigree Law:  Historic Change To Commerce” that pointed out the significant change that was then scheduled to occur once the California law was to go into full effect in 2016.  Of course, that state law was preempted by the Drug Supply Chain Security Act (DSCSA) back in 2013 so we never actually experience that change.  But what about the DSCSA?  Will it change the way commerce happens in a historic way?  Let’s take a look.

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PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders

Last week the Pharmaceutical Distribution Security Alliance (PDSA) held a workshop for interested stakeholders to brainstorm just how their proposed independent, balanced and sector-neutral organization might meet their vision.  This was the follow-on meeting tied to the publication of two documents last month that provided their “vision” and the actual proposal for the organization (see “PDSA’s Proposal for Governance of DSCSA Phase II Interoperability”). 

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An Aggregation ‘Discussion’

Trade item, logistics unit…or both?

Aggregation of saleable drug packages to shipping cases and pallets is not required by the US Drug Supply Chain Security Act (DSCSA) or the EU Falsified Medicines Directive (FMD) or the related Delegated Regulation (EUDR).  But certain business processes in the EU under the FMD will be difficult to accomplish without it, and after November 2023, the operation of the supply chain in the US will not be efficient without it (see “Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation”, “EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary” and “Pharma Aggregation: How Companies Are Achieving Perfection Today”).  Absent a mandate, companies need to recognize, themselves, just how vital aggregation is to their businesses and prepare to generate it and/or make use of it.

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Global Regulators Recommend Track & Trace Interoperability Features

Back in the fall of 2017 the International Coalition of Medicines Regulatory Authorities (ICMRA) published a paper containing recommendations for pharmaceutical product regulators around the world to consider for achieving future interoperability of national or market pharma track and trace systems.  That is, their recommendations were aimed at enabling interoperability between and among the various current and future pharma track & trace regulated systems around the globe.  For example, their recommendations could help the US FDA exchange and accept information from the European Medicines Verification System (EMVS), and vice versa.  In this way, regulators in each market could learn about problems with drug products circulating within each other’s markets.  Why would you want to do such a thing?  Let’s take a look at their 2017 paper.

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Global Differences In Expiration Date Encoding

Last week the European Medicines Verification Organisation (EMVO) sent a letter to all of their “Onboarding Partners” (OBPs), or drug marketing authorisation holders (MAHs) informing them of a problem EMVO is seeing with many of the expiration dates on drugs being uploaded.  The problem they highlighted in the letter has been recognized by people around the world, and each country has decided to handle it slightly differently.  Drug manufacturers should be aware of these differences to ensure compliance and avoid false failed verifications.  Let’s take a closer look at the issue and what each country expects you to do about it.

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Blockchain And Track & Trace Models

Blockchain technology is also known as “Distributed Ledger” technology.  That is, a sequential ledger is shared (distributed) amongst a group of people/entities.  This terminology, at least, seems to imply that blockchain would be a good way to represent—in digital form—the transactions in a supply chain, which are distributed geographically and over time.  Way back in 2011 I posted an essay aimed at analyzing the viability of three different ways of digitally modeling the pharma supply chain.  I called it, “The Viability of Global Track & Trace Models”.  I’d like to revisit that essay to see how blockchain technology might affect my conclusions.

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PDSA’s Proposal for Governance of DSCSA Phase II Interoperability

Independent, balanced, sector-neutral

Last week, the Pharmaceutical Distribution Security Alliance (PDSA) published two papers aimed at kickstarting the creation of a new non-profit organization that would accept the responsibility for setting up and executing governance over Drug Supply Chain Security Act (DSCSA) phase II interoperability (see “A Serious DSCSA Governance Organizational Proposal Emerges From PDSA”).  PDSA defines “DSCSA phase II” to be the same as what the DSCSA text calls the “Enhanced Drug Distribution Security” (EDDS) phase (see “EDDS: The New Data Exchange Requirements”).  The EDDS phase (err, Phase II of the DSCSA) starts on November 27, 2023.  In most informal conversations this phase is usually just referred to as “2023”. 

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