All posts by Dirk A. Rodgers

China Inches Closer To Another Pharma Serialization Mandate

In late August, the China National Medical Products Administration (NMPA) issued three new drug and vaccine traceability guidance documents.  Then in mid-September, they issued five draft documents for comment related to the data exchange protocol for drug traceability.  Based on those publications, it appears that China really is accelerating their move toward traceability of drugs (see “China Commits To The Digital Future In Healthcare, Including Pharma Traceability”).

Continue reading China Inches Closer To Another Pharma Serialization Mandate

Pharma Counterfeiter Strategies In a Track & Trace World

What is a counterfeiter to do today?  Governments around the world are moving toward standardized serialization and track & trace requirements aimed directly at their bottom line.  It’s getting harder to fake your way past supply chain workers who are increasingly educated on what to look for and how to raise their suspicions to the authorities.  Or is it?  Let’s take a closer look.

Continue reading Pharma Counterfeiter Strategies In a Track & Trace World

Mixed Signals From Russia

I’m not talking about the mixed signals from Russia in your daily political newsfeed, I’m talking about the mixed signals we see between the Russian Federation decrees for their pharma serialization and traceability mandate, and the announcements of the government’s designated technology contractor to develop that system:  CRPT, LLC.  Considering how short the deadlines are, these mixed signals are counterproductive because they cause companies to pause while they figure out what they should do.  Let me explain.

Continue reading Mixed Signals From Russia

Sponsored: Newly Updated Global Serialization Regulation Map

I just helped IQPC update their printable global pharma serialization regulation map.  Get a copy here.  Things change around the world pretty often so it’s important to update resources like this frequently.  The information for most of the existing countries was updated and I added a few new countries.  It’s a great resource to print and pin up on your office wall, or the company bulletin board to keep everyone focused on the approaching deadlines around the world.  And it looks great too! Continue reading Sponsored: Newly Updated Global Serialization Regulation Map

The Most Head-Scratching Section Of The FMD

I found this sealed OTC product in my own closet. Note the round clear adhesive seal between the four yellow arrows. Would this anti-tamper seal render this product illegal in the EU after next February?

Just after I posted my last FMD essay on RxTrace (see “FMD, One Year Out”) I found out that the European Commission had published version 9 of their “Safety Features for Medicinal Products for Human Use, Questions and Answers”.  This is must reading for anyone with questions about how to interpret the most confusing provisions of the Falsified Medicines Directive (FMD) (also known as EU Directive 2011/62 and which amends Directive 2001/83) and the Delegated Regulation (EUDR) (also known as EU Regulation No 2016/161) (see “The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning“).

With each major revision this Q&A document grows.  This time it grew substantially with the addition of 21 new questions and answers and updates to four previously posted answers.

But there is one provision of the FMD that defies explanation, even though the Q&A document burns two Q&As to attempt it.  That provision in the FMD is Section 1 of Article 45a, which basically says, in part, that you cannot put an anti-tamper device on non-prescription drugs unless the EC or a Member State specifically says you can.  What’s going on here? Continue reading The Most Head-Scratching Section Of The FMD

DSCSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure, Again

iStock_000021010135XSmallA couple of days before President Obama signed the DQSA legislation back in 2013 I published an RxTrace essay that looked at what was going to be necessary in the next year from the FDA and the industry (see “DQSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure“).  The initial standards necessary at that time were for data exchange, and the FDA had one year to come up with them.  My essay was about the need for the industry to work with the FDA to come up with the standards that would work.  The FDA didn’t have the expertise or the knowledge of how the supply chain operated and so I felt it was imperative for the industry to help them out.

Fast forward to today.  Rather than data exchange standards, the FDA is facing Continue reading DSCSA: The U.S. Pharma Supply Chain Must Organize, Or Risk Failure, Again

The New GS1 US DSCSA Implementation Guidance Suite

A few weeks ago, GS1 US published version 1.2 of the DSCSA implementation guidance that documents how to apply GS1 standards when meeting the U.S. Drug Supply Chain Security Act (DSCSA).  GS1 US is the GS1 Member Organization (MO) in the United States, of GS1, the global supply chain standards organization.  Companies who market drugs in the U.S. pharma supply chain and their solution providers will find this new version to be an indispensable resource that will Continue reading The New GS1 US DSCSA Implementation Guidance Suite

#BlackLivesMatter Explained By A White Guy

iStock_5179418_SmallerDon’t worry.  It is not my intention to change this pharma/regulatory/technology blog into a political platform, but after the events of last week, I think it is appropriate for all of us to step back and examine how we can make our country better.  I believe I can make a positive contribution by explaining my sincere interpretation of #BlackLivesMatter.  I first heard the phrase “Black Lives Matter” back in 2012 when Travon Martin was killed by George Zimmerman in Sanford, Florida.  Like most people, when I first heard the phrase, I thought it was clearly wrong.  I thought, what they should say, is “all lives matter”. Continue reading #BlackLivesMatter Explained By A White Guy