Apparently, the National Agency of Sanitary Surveillance (ANVISA), Brazil’s pharma regulatory body, has passed a resolution that finally suspends all remaining serialization deadlines that were left over in their old RDC-54 regulation. Remember that they suspended the deadline for the 3-lot pilot from RDC-54 last year (see “The Official Suspension of the Three-Lot Pilot in Brazil“). I consider this news to be a “rumor” only because I have not yet seen the official word, despite having heard it from a very reliable source.
This is not Continue reading Sponsored: Brazil Officially Suspends All Remaining Serialization Deadlines Of RDC-54
While I was preparing a DSCSA resource list to be handed out at the 
The FDA is almost 10 months behind in the release of guidance documents for the 
There are lots of mistakes a company can make when designing their solution to comply with pharma serialization and tracing regulations. One of these is to print the unique identifier on the outsert attached to their packaging. An “outsert” is a tightly folded piece of paper that contains very detailed prescribing information intended to inform medical professionals who prescribe, dispense and/or administer the drug. It contains 
The government of Brazil is trying to recover from the poor design of their first attempt at a pharma serialization and tracing regulation, 
The 
There is a long-running tug-of-war going on between GS1 and national governments around the world over how exactly to identify medical products, whether devices or pharmaceuticals. National governments regulate those products to maximize the health of their citizens and so they take a natural interest in how they are identified. They want to eliminate all ambiguity between products within their market. They need to be able to tightly grant market authorization, revoke it and oversee recalls when warranted. To do that effectively, they need a way of clearly and concisely referencing a given product. That same way of referencing the product should also be used for patient education and for healthcare professional prescribing. 
Last week the US FDA 