Last week, Brazil’s pharma industry regulatory agency, the National Agency of Sanitary Surveillance (ANVISA), announced that they were “suspending” at least part of RDC-54/2013, the declaration that mandated drug serialization and tracing, until further notice. Thank you to all who forwarded the link to the official announcement. I was able to translate and read it on Thursday, and I submitted a comment on my own last essay, “Pharma Serialization Deadlines In Flux“, to include the link. Apparently shortly after that essay was published, ANVISA publicly announced the suspension.
However, the ANVISA website was inaccessible in the United States Sunday afternoon when I normally write RxTrace essays so I was unable to finish this essay until Monday morning. Now that I can access the site, here are the details.
According to a translation of a news article published on the ANVISA website, what they have done is to suspend item II of Article 23 of RDC 54/2013. That’s the section the mandates the 3-lot pilot by each registration holder that was to be completed by December 10 of this year. Apparently ANVISA will publish a new RDC that will officially revoke that requirement “in the coming days”.
In addition, it appears that the entire regulation will be reviewed and the design of the mandated solution potentially reconsidered.
In my view, RDC 54/2013 mandated data exchanges that were excessive and duplicative, but the worst part about that regulation is that it makes registration holders responsible for collecting tracing data from all downstream trading partners. The article indicates that the board members nodded in agreement with the centralized tracing model, but it is unclear if that indicates support for a simplified centralized model, a semi-centralized model (see “The Viability of Global Track & Trace Models“), or the one they current have as defined in RDC 54/2013 (which is more of a convoluted hybrid model, in my opinion).
Also unclear is whether this action changes the deadline for full serialization and tracing, previously specified by RDC 54/2013 as December 10, 2016. The article only mentions the suspension of the pilots but others have indicated that they expect, or they believe, that the 2016 deadline is, or will be, suspended as part of the review and reconsideration. Treat this as more rumor until it is confirmed by an official announcement. Hopefully that will come soon, so stay tuned.