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’
Lots of people have been talking lately about what interoperable data exchange in the US pharma supply chain will look like after the Enhance Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA) takes effect in November 2023 (see “Does Interoperability Change In 2023?”, “5 Myths About The DSCSA In 2023” and “Interoperability And The DSCSA”).
Increasingly, I’ve heard the opinion expressed that there will surely be multiple approaches adopted for exchanging data, and so it will be necessary for all of those approaches to be made interoperable with each other. Proponents of this idea claim it is unrealistic to expect a single approach to be accepted by all companies in the supply chain and therefore, having to deal with multiple approaches is inevitable. This kind of talk makes me nervous. Here’s why.Continue reading DSCSA: Interoperable Data Exchange In 2023
Beginning in less than two weeks, all packages of prescription drugs entering the EU pharma supply chain must contain a 2D barcode encoding the EU serialized ‘Unique Identifier’ (see “The ‘Unique Identifier’ in the EU Delegated Act”). More importantly, all drugs that have an FMD unique identifier on them at the point of dispense after February 9, 2019 must be “verified” and decommissioned through the National Medicines Verification System (NMVS) (see “What’s So Hard About Unique Identifier Verification?” and “Decommissioning Under the FMD/EUDR”). It looks like my prediction of FMD delays was wrong (see “How Will They Delay The FMD?”) but at least Denmark has just moved to solve a serious FMD dilemma with a kind of delay. Let me explain.Continue reading FMD: Denmark Moves To Solve FMD Dilemma
Congratulations, you’ve just connected to the EU Hub and you are authorized to begin uploading production data ahead of the February 9, 2019 deadline. It’s been a long road. Most pharma marketing authorisation holders (MAH) report taking six months from initial onboarding application to authorization. Now what? Continue reading FMD: Your Initial Upload To The EU Hub
The EU Delegated Regulation (EUDR) of the Falsified Medicines Directive (FMD) mandates that all serial numbers placed on non-exempt drugs entering the EU supply chain after February 9, 2019 must be ‘sufficiently randomised’. What is sufficient randomisation? The regulation says one thing, and the European Medicines Verification Organization (EMVO), the operator of the EU Hub, says something beyond that. What should drug manufacturers do? The EMVO recently updated their messaging. Let’s take another look at this important topic. Continue reading EMVO Admits, ‘Insufficient Randomisation’ Warnings Can Be Ignored
Neither the Drug Supply Chain Security Act (DSCSA) in the United States, nor the Falsified Medicines Directive (FMD) in the European Union explicitly mandates the capture or use of aggregation data (see “Aggregation –> Chargeback Accuracy –> ROI” and “EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary“). In this instance, “aggregation data” is data that documents the serialized packaging containment hierarchy of drug products—also known as “parent-child relationships”. It is well established that companies are not required by law to capture it, but for the smooth operation of pharma supply chains under a serialization, tracing and/or verification regulation, high quality aggregation data will be necessary. But there are warning signs that a significant percentage of drug manufacturers are not going to meet that bar by the deadlines. Continue reading Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation
The era of personalized medicines has begun. These are medicines that are tailored specifically for a single patient, using that patient’s specific DNA or other blood characteristic as a guide or actual source component. The new chimeric antigen receptor T-cells (CAR-T) is an exciting example. It results in the conversion of a patient’s own T-cells into cells that are able to recognize the specific type of cancer cells that the patient has, and thus able to attack them in the same way that normal T-cells attack normal infectious cells. In short, it’s a way of manipulating a person’s own immune system to attack cancer cells that it would normally be blind to. When it works, the results can be breathtaking. The question is, how are these drugs treated under today’s serialization and tracing regulations? Let’s take a look. Continue reading Personalized Medicines In A Serialized World