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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A Serious DSCSA Governance Organizational Proposal Emerges From PDSA

PDSA Members (click image to enlarge)

Two days before the Drug Supply Chain Security Act (DSCSA) was signed by then President Obama, I published “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure”.  Under the heading “Who should organize and start the effort [to organize the industry around solutions to the DSCSA]?”, I wrote:

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The New GS1 Digital Link Standard

There is competition in the 2D barcode world between Data Matrix, QR Code and PDF417.  Which do you like?  Why?  Before you choose, do you know the features and benefits of each so you can make an intelligent choice?  Now that I’ve asked all those questions, I need to take a step back. For meeting the U.S. Drug Supply Chain Security Act (DSCSA), Congress already made the choice for you.  It’s the same in the E.U., the European Commission made the same choice.  They both picked Data Matrix.  You can’t use QR Code or PDF417 or any other kind of barcode or RFID on prescription drug packages in those markets, or you won’t be compliant and your trading partners won’t want to do business with you.  Does that bother you?  It shouldn’t.  The problem is, some countries around the world are flirting with mandating QR-Codes for drugs rather than Data Matrix. 

Let’s take a look at these three types of barcodes, and in the process, we’ll take a closer look at GS1’s new Digital Link Standard.

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Russia: CRPT Posts Test Methodology For Crypto Code

CRPT, the company authorized to conduct the development, piloting and operation of the Russian government pharmaceutical serialization and tracing system, posted an important document last week.  The document is intended “…to unify the process of testing printing on the packaging of medicinal products of identification features using the verification code and electronic signature with the content in it of a different number of characters and the aggregation process of drug manufacturers to obtain comparable test results and their applicability in the framework of industrial implementation.”  Will it help you? 

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DSCSA: What Wholesalers Want

Last November pharma manufacturers selling into the U.S. market had to meet a big serialization and verification deadline under the Drug Supply Chain Security Act (DSCSA).  Now, pharma wholesale distributors in the United States are facing their own important deadline this coming November.  Remember how manufacturers had to scramble and go through a lot of pain to achieve compliance in time?  Your friendly neighborhood wholesale distributors—big and small—are going through that now.  And the problem is…they can’t do what they need on their own.  They need all drug manufacturers to do something so that they can be compliant with the DSCSA in November.

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DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.
The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel
and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating
the positions of any company, organization or individual other than Dirk Rodgers.

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