Tag Archives: pharma traceability

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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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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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  Then last summer, a new government agency, the National Medical Products Administration (NMPA), posted three draft guidance documents for review and comments (see “China Posts New Draft Pharma Serialization Guidelines”).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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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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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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Sponsored: IQPC: The Biggest Challenges Preparing For The DSCSA

Kevan MacKenzie, Director of Serialization Technology at McKesson

Kevan MacKenzie, Director of Serialization Technology at McKesson, is arguably the leading expert on the Drug Supply Chain Security Act (DSCSA) requirements for wholesale distributors, and interactions with their trading partners.  IQPC recently interviewed Mr. MacKenzie to get his perspectives on the biggest challenges companies face when preparing for the DSCSA.

MacKenzie’s insights will Continue reading Sponsored: IQPC: The Biggest Challenges Preparing For The DSCSA

HDA Traceability Seminar: RxTrace Future Topic List Explodes

The 2017 Healthcare Distribution Alliance (HDA) Traceability Seminar is now in our rearview mirror.  We’ll have to wait another full year for the next one.  As usual, this year was filled with the most pertinent presentations and conversations for those interested in serialization and traceability in the US pharma supply chain—particularly in meeting the Drug Supply Chain Security Act (DSCSA).  I use events like this to discover really great new topics that need to be covered in RxTrace in the future, and this year, this event (including the IEEE Blockchain pre-event) resulted in an explosion.  That is, an explosion in the number of good topics to cover. Continue reading HDA Traceability Seminar: RxTrace Future Topic List Explodes

Why Aren’t Health Insurance Companies Interested In Pharma Traceability in the US?

Except for Medicare/Medicaid, the United States and Australia are the only countries in the world that do not rely primarily on “single-payer healthcare”.  The term refers only to who pays for the healthcare of citizens, not how that care is delivered.  Those two countries rely primarily on private insurance companies to act as “payers” of healthcare for most citizens and the funds used to pay are Continue reading Why Aren’t Health Insurance Companies Interested In Pharma Traceability in the US?