Some countries mandate the use of GS1 standards for drug product identification and package and case barcodes. The European Commission seems to tolerate GS1 standards, leaving it up to each member state to decide. Most use them, a few held onto their own national codes as long as they could. China is taking their time warming up to the GS1 Global Trade Item Number (GTIN) but it seems to be happening. That is, I think it’s happening. The United States has always had its own national numbering system for identifying drugs, known as the National Drug Code (NDC) (see “Anatomy Of The National Drug Code”). Because they are running out of numbers to identify new manufacturers (labelers), they are considering changes to the NDC that could break the ability to encode an NDC within a GTIN (see “How To Properly Define GTINs For Your NDCs”, “FDA New NDC Format Public Meeting” and “An Open Letter To The FDA: New NDC Format Public Meeting”). The USA is not the only country to be considering a break with GS1 standards. Indonesia will allow QR Codes on drug packages, and now there is a movement in the India government to move away from GS1 standards. What’s going on here? Can GS1 hold onto drug identification around the world? Let’s take a look.Continue reading Can GS1 Hold Onto Drug Identification Worldwide?
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.Continue reading Meet The Latest GS1 Key: The Global Model Number (GMN)
The Russia Ministry of Health (MoH) is conducting a serialization and tracing pilot with a number of supply chain members between February 1, 2017 and December 31, 2017 (see “Russia Begins Its Pharma Supply Chain Pilot”). The MoH is due to publish an assessment of the pilot by next February 1st.
Two weeks ago the Russian Minister of Health, Veroníka Skvortsova, signed the guidelines document for the pilot. The 42-page document appears to be written as a pilot setup document, as opposed to Continue reading The Russia Serialization Pilot Guideline
Over the last few weeks, the pharma serialization and tracing landscape has begun to shift in China. The China Food and Drug Administration (CFDA) announced a new use for an existing “National Drug Code” in Public Notice 2017-1 that, according to Google Translate (a helpful but very imperfect translator), will be referred to as the “Bit Code”. In addition, a new notice has appeared on the AliHealth-hosted web portal that drug companies have been using for the last seven years or so to obtain serial numbers for their drug packages. Automated translation tools leave too much to speculation so companies should not use them for compliance purposes. However, here are my thoughts/speculation on what is happening. Continue reading The Intrigue Contained In The New China Drug Code
Last week the FDA published draft, non-binding guidance for their recommended unique facility identifier (UFI) for use in registering foreign and domestic drug establishments. Last year, Congress passed the FDA Safety and Innovation Act (FDASIA) to address safety concerns induced by inspection gaps of facilities outside the United States and other issues (see “The Supply Chain Provisions Of The FDA Safety & Innovation Act”). In that law, Congress required the FDA to come up with some way of uniquely identifying all foreign and domestic facilities that are involved in the manufacture and importation of drugs. This new guidance is the response. Continue reading FDA Chooses DUNS For Unique Facility Identifier
That’s right. GS1 and HIBCC are in a multi-year fight over the dominance of their standards within the U.S. healthcare supply chain. Continue reading WAR: GS1 Vs. HIBCC