China Commits To The Digital Future In Healthcare, Including Pharma Traceability

Tesla Gigafactory 3 near Shanghai, China, June 22, 2019. Screengrab from YouTube video posted by Jason Yang.

I finally had time to finish applying Google Translate to the document issued on May 23, 2019 by the Comprehensive and Planning Finance Department of the China National Drug Administration (CNDA), called “State Drug Administration:  Action Plan to Accelerate the Promotion of Smart Drug Supervision”.  I originally thought “Smart Drug Supervision” was solely related to supply chain supervision, serialization and traceability, but that’s only a part of their plan.

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Barcodes 45, RxTrace 10

The commercial use of barcodes began 45 years ago last week, and RxTrace began 10 years ago this week.  These are pretty incredible milestones and it is worth stepping back and thinking about what it all means.  GS1 issued a press release about the barcode’s 45th anniversary last week, providing links to several videos.  These include some old-timey videos of what grocery checkout was like before barcodes, and when the UPC barcode was first introduced in Troy, Ohio in 1973.  It made me feel old. 

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Here We Go Again. Florida Flirts With Opening Door To Counterfeits

Earlier this month, the state of Florida (population:  21 million) passed a law that seeks to enable the importation of drugs from Canada (population:  37 million).  The goal is to carve out some way for Florida residents to take advantage of the lower drug prices that Canadian citizens enjoy.  Canada is a “single payer” healthcare country, except for prescription drugs, which are not covered by the Canadian universal public health insurance system.  The reason some drugs are cheaper in Canada than they are here in the US is because the government is allowed to negotiate with drug companies to set pricing for their citizens.  But in the US, Congress has specifically denied that option for itself, except for Medicare.

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Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?

On November 27, 2019 the Drug Supply Chain Security Act (DSCSA) requires wholesale distributors to step up their supply chain security activities another notch.  They are required to:

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Meet The Latest GS1 Key: The Global Model Number (GMN)

GS1 makes modifications and additions to their General Specifications every year—sometimes even twice a year.  The latest is version 19 and was published in January 2019.  The “GenSpecs” contain the full detailed definitions of every GS1 “key” and every GS1 barcode.  While it doesn’t contain the definitions of every GS1 standard, it is the catch-all specification for their traditional core—mostly barcode related—standards.  This is where GS1’s keys are defined, included the Global Trade Item Number (GTIN, Application Identifier, or AI = 01), Global Location Number (GLN), Serial Shipping Container Code (SSCC, AI = 00), Global Returnable Asset Identifier (GRAI, AI = 8003) and all the others.  Last year (GenSpecs version 18) GS1 introduced their latest key, the Global Model Number (GMN, AI = 8013).  It’s an important addition, particularly for healthcare.  Let me explain.

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China: NMPA Drug Traceability Guidance

Most RxTrace readers will recall that China was an early adopter of drug traceability.  Back in 2007, companies were required to begin printing unique identifiers in linear barcodes on certain drug packages.  The unique identifiers had to be purchased from a government contractor.  The list of drugs grew each year to the point where all drugs were effectively covered by early 2016.  But shortly after that, the whole requirement was suspended (see “China’s Retreat From Pharma Serialization: Will This Become A Global Trend?” and “China Adds Traceability Requirement To CFDA Drug Quality Management Specification”).  Then last summer, a new government agency, the National Medical Products Administration (NMPA), posted three draft guidance documents for review and comments (see “China Posts New Draft Pharma Serialization Guidelines”).  Finally, last month, the NMPA published two of those documents in final form, “Implemented on April 19, 2019”. 

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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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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
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the positions of any company, organization or individual other than Dirk Rodgers.

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