If you do business in Brazil then you know that everything is published there in Portuguese, including ANVISA’s documents. It is necessary to translate everything unless you can read Portuguese. I can’t, so whenever something comes out I have to do a quick translation to get an idea of how significant it is. Last week, ANVISA published two new documents related to their future pharma serialization and traceability mandate. They are important, because they relate directly to the schedule and some of the requirements of Brazil’s pharma serialization and traceability mandate.Continue reading Brazil Moves to Formalize A Phased Rollout, Starting Next October
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.Continue reading Brazil: The Anvisa 2019 Pilot Report
CRPT, the company authorized to conduct the development, piloting and operation of the Russian government pharmaceutical serialization and tracing system, posted an important document last week. The document is intended “…to unify the process of testing printing on the packaging of medicinal products of identification features using the verification code and electronic signature with the content in it of a different number of characters and the aggregation process of drug manufacturers to obtain comparable test results and their applicability in the framework of industrial implementation.” Will it help you?Continue reading Russia: CRPT Posts Test Methodology For Crypto Code
Last week, GS1 Healthcare raised the awareness of new documents available on the Russian Federation government website. Actually, the news was contributed to that group by Brian Daleiden of TraceLink, who has been very generous with contributions of news and documents from multiple markets. These Russian documents explain the basis for a voluntary pharma supply chain pilot that the government is beginning this quarter. Of course, these documents are only provided officially in the native Russian language. Continue reading Russia Begins Its Pharma Supply Chain Pilot
The Healthcare Distribution Alliance (HDA) Traceability Seminar that was held back in early November was so packed with valuable information that I still have a number of topics queued up from that event for RxTrace essays in the future. Today I want to take a closer look at the results of the Saleable Returns Pilots conducted by the HDA last year to figure out the most efficient way to verify saleable returns. I discussed the overall project in my report of the Traceability Seminar (see “HDA Delivers Home Run To Record-Breaking Audience”) but today I want to focus in on just two of the approaches piloted. These are:
- Manufacturer sends to wholesale distributor product identifiers for only the units purchased by that wholesale distributor, and,
- Verification Router Service (VRS).
I was initially disappointed in the FDA Drug Supply Chain Security Act (DSCSA) Pilots Workshop that was held at FDA headquarters last week, but in the end, the outcome appeared to fit the need. Going in, I knew not to expect the FDA to convey any information to the attendees, so that is not why I was disappointed. I attended the public DSCSA workshop they held back in May of 2014 so I already knew their typical approach for workshops like these (see “The 2014 FDA DSCSA Workshop”). I knew that the purpose of the workshop was to inform the FDA, not to inform the attendees. I would estimate that about one out of every four attendees were expecting the opposite, and I would bet a significant percentage of those had not even read the DSCSA once. But that’s not why I was disappointed.
I was initially disappointed because Continue reading The 2016 FDA Pilots Workshop
As we saw last fall, the FDA is planning to conduct at least one pilot project in 2016 to fulfill its DSCSA mandate to do so. The pilot should focus on the 2023 DSCSA technologies and processes (see “FDA Looking For Consulting Org To Run DSCSA Pilots“). Today we learned that a pilot will indeed occur this year, and the FDA wants your input into its design and goals. To accomplish that quickly, the FDA will establish a docket next Tuesday for collecting written comments, and a public workshop for collecting verbal comments.
The last DSCSA public workshop Continue reading FDA To Hold DSCSA Pilots Workshop