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:Continue reading Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?
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 Then last summer, a new government agency, the National Medical Products Administration (NMPA), posted three draft guidance documents for review and comments (see “China Posts New Draft Pharma Serialization Guidelines”).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”.Continue reading China: NMPA Drug Traceability Guidance
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.Continue reading Global Regulators Recommend Track & Trace Interoperability Features
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.Continue reading Blockchain And Track & Trace Models
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
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
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?
Last week, Brazil President Michel Temer signed law number 13,410, which amends law number 11,903 from 2009, their original pharma serialization and tracing law. The effect of the new law on the old can be seen here. The problem for me is that I don’t read Portuguese, so I must rely on Google Translate to translate these texts. This results in an unofficial translation that has a few imperfections that are obvious, even to non-Portuguese readers, but it appears to be not bad. Continue reading Brazil Gets Rational With Their New Pharma Traceability Law