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?
One of the best sessions during last week’s LogiPharma conference held in Princeton, NJ was called “Staging Your Implementation To Meet The 2017 Deadline”. The “deadline” refers to the November 27, 2017 deadline for drug manufacturers to apply unique serial numbers to all drug packages and cases shipped into the U.S. market as required in the Drug Supply Chain Security Act (DSCSA), but it can also refer to similar deadlines with similar requirements in a number of other regions of the world. The panel included knowledgeable representatives from two of the largest global pharma manufacturers selling into the U.S. market. Both manufacturers are facing serialization mandates in the E.U., Brazil, Turkey, South Korea, China, India, Argentina and a few countries in Africa as well as the U.S.
As they spoke about their respective programs for meeting the requirements, one of the speakers mentioned that roughly 90% Continue reading Pharma Serialization: Going Totally Global Soon