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.
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.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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