Right now we are waiting for major new announcements regarding serialization and tracing requirements in the United States (4 overdue FDA guidance documents), the European Union (final publication of the Delegate Act related to the Falsified Medicines Act), Brazil (major redesign of their regulation), and Russia (first official publication of their regulation). But last week, the India Directorate General of Foreign Trade (DGFT) published a new public notice containing details of the “Implementation of the Track and Trace System for Export of Pharmaceuticals and Drug Consignments”. These details are for drugs made in India but exported to other markets. Continue reading India Posts New Deadlines (Again) For Serialization Of Drug Exports
All posts by Dirk Rodgers
‘An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?’, Again
I hope your holidays were filled with love and cheer. Mine were. It was great. So great, in fact, that I did not have time to write a brand new essay for today. Not much has happened lately since we are still awaiting publications from the FDA, the EC and ANVISA (and others), Instead, here is one of my best essays from 2015, reposted as it appeared on August 31, 2015 without modification (see “An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?“). I’m even leaving in the off-season references. If you read this essay back then, you might enjoy it again. If you did not read it back then, I recommend that you read it now. Let me know what you think.
Before we begin, if you have not yet responded to the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz, please to so now. It is open to everyone and the survey will be closed soon.
RxTrace Preview of 2016
It’s time to think about what is likely to happen in 2016 with regard to pharma serialization and traceability. As part of that, let me remind you right off the top to fill out the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz. You don’t have to be a subscriber to respond and the results will also be open to everyone in the coming months.
So what about 2016? I think Continue reading RxTrace Preview of 2016
What The DNC Data Breach Means To The Future Of Traceability Data Repositories
Those of you who are paying close attention to the presidential election campaigns in the United States late last week were treated to a news story that may be a preview of stories that will be written at some point after 2023. The story is about the potential game-changing impact of technology on business when competitors are forced to share a data repository. That is, when private data that would be considered strategically valuable, in some way, if a competitor were to gain access to it, is held by an independent third-party.
In this case, Continue reading What The DNC Data Breach Means To The Future Of Traceability Data Repositories
FDA Still Receives Requests For Exemptions From 2006 Barcode Rule
This morning the FDA is due to publish an announcement for an opportunity to comment on their proposed collection of certain information as part of ongoing requests for exemptions from the linear “barcode rule” that has been in effect since April 26, 2006. The FDA is soliciting comments on the barcode label requirements for Continue reading FDA Still Receives Requests For Exemptions From 2006 Barcode Rule
HDMA Updates Q&A For DSCSA
I was on the HDMA’s website last week doing some research for one of my clients, and I found that the HDMA has updated their highly regarded Q&A document that provides answers to questions related to the U.S. Drug Supply Chain Security Act (DSCSA). I have reviewed this document before in its previous incarnation and view it as one of the best resources out there for all supply chain participants (see “InBrief: HDMA Updates DSCSA Q&A“). Each time they update it they Continue reading HDMA Updates Q&A For DSCSA
Sponsored: Tell The FDA About Your Progress Toward The DSCSA Serialization Deadline, Anonymously
This is a “sponsored” essay, which simply means it is free to everyone and does not count against their one free essay per month for those who are not full subscribers. The reason for that is to maximize the number of people who have the opportunity to tell the FDA how they are progressing toward the DSCSA serialization deadline, and do so anonymously. Continue reading Sponsored: Tell The FDA About Your Progress Toward The DSCSA Serialization Deadline, Anonymously
Lack Of Preparedness By CMO’s Imperils Pharma Manufacturers
Everywhere I traveled this fall I had conversations with people from drug manufacturers who told me their top concern right now is that their contract manufacturers (CMOs) or contract packagers (CPOs) are not taking the actions necessary to be prepared to meet the approaching serialization mandates in the U.S., the E.U. and elsewhere on time. This threatens the manufacturer’s ability to be ready for those deadlines and they are grasping for something they can do now to fix the situation before it gets too late…if it isn’t too late already. Continue reading Lack Of Preparedness By CMO’s Imperils Pharma Manufacturers
