Earlier this month the Russian Federation finally amended Decree #1556 to cut the length of the Signature portion of the crypto-code element of their pharmaceutical unique identifier in half. Will that solve the problems the industry uncovered, like the barcode taking up so much space and slow read performance? Let’s take a closer look at it, but first, a review.Continue reading Russia Officially Cuts Length of Crypto-code in Half
Ahh, summer. Some years it seems like everyone is on vacation except me. I usually only take a few days off here and there in the summer, preferring to do longer vacations in other parts of the year. So next weekend I’m going to take an extra day off, and so there will be no RxTrace essay published next Monday (the Labor Day holiday here in the US), and I’m going to link to one of my favorite essays from the last year this week as the summer winds down. This essay was posted on October 7, 2018 under the “A Monthly Slice of RxTrace” on the Center For Supply Chain Studies (C4SCS) website. Unfortunately I haven’t been able to keep up with the “Monthly” part of that title due to time pressures, but there is some great content out there from the last 12 months (see “A Monthly Slice of RxTrace”). Other than my diverted attention, nothing has changed so I may post more new content on the C4SCS site in the future if I can make some time.Continue reading DSCSA Uniqueness: SNI vs SGTIN…Again
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 Then last summer, a new government agency, the National Medical Products Administration (NMPA), posted three draft guidance documents for review and comments (see “China Posts New Draft Pharma Serialization Guidelines”).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
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.Continue reading Brazil: The Anvisa 2019 Pilot Report
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.Continue reading DSCSA: Historic Change To Commerce
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.Continue reading An Aggregation ‘Discussion’
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