The pharmaceutical markets that currently have a serialization and/or tracing regulation on the books include the United States, the European Union, China, Brazil, India, Italy, Turkey, South Korea, Argentina, Saudi Arabia and Jordan. Not all are fully operational yet, but they are official. This list may be about to grow by two. Continue reading The Next Markets To Impose Pharma Serialization and Tracing?
Category Archives: Global Alignment
Global Traceability Data Exchange: Troubled Waters Ahead
As we near the end of 2014, several important pharma traceability deadlines around the world are approaching. Besides the U.S. Drug Supply Chain Security Act (DSCSA), these include deadlines in Brazil and South Korea. Of course, each regulation is different. Now that the initial implementation of the exchange of transaction data in the U.S. is widely being implemented in Electronic Data Exchange (EDI) Advance Ship Notices (ASNs), the next hurdle for drug manufacturers will be to deploy serialization technologies on their U.S. and Korea market packaging lines. The data exchange technology problem will shift to Brazil, and that’s where I see trouble. Continue reading Global Traceability Data Exchange: Troubled Waters Ahead
Pharma Serialization: Going Totally Global Soon
One of the best sessions during last week’s LogiPharma conference held in Princeton, NJ was called “Staging Your Implementation To Meet The 2017 Deadline”. The “deadline” refers to the November 27, 2017 deadline for drug manufacturers to apply unique serial numbers to all drug packages and cases shipped into the U.S. market as required in the Drug Supply Chain Security Act (DSCSA), but it can also refer to similar deadlines with similar requirements in a number of other regions of the world. The panel included knowledgeable representatives from two of the largest global pharma manufacturers selling into the U.S. market. Both manufacturers are facing serialization mandates in the E.U., Brazil, Turkey, South Korea, China, India, Argentina and a few countries in Africa as well as the U.S.
As they spoke about their respective programs for meeting the requirements, one of the speakers mentioned that roughly 90% Continue reading Pharma Serialization: Going Totally Global Soon
The Future of Healthcare Supply Chain Security
Let’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future. Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how healthcare supply chain security will work In 2024 than looking forward in any previous 10 year period. In the last two years the U.S. and the E.U. have enacted legislation and introduced regulations that will have a profound impact on the security of these major supply chains in ten years. These include:
- In the U.S.:
- In the E.U.:
- The Falsified Medicines Act (FMA)
- The Harmonized Unique Device Identification Framework
- The anticipated Delegated Acts related to the FMA
Continue reading The Future of Healthcare Supply Chain Security
Sponsored: Transatlantic Alignment
Happy Martin Luther King day! Today we have a special guest blog essay by Mark Davison of Blue Sphere Health in the U.K.. Mark is the author of the book, “Pharmaceutical Anti-Counterfeiting”, published by Wiley in 2011. – Dirk.
Pharmaceutical traceability (in its various nuances of serialization, aggregation, track and trace, epedigree etc) has been proposed, debated, boosted and resisted for a very long time. The labyrinthine twists and turns have been examined in near real time on RxTrace and I won’t revisit them here. However, the passing of the Drug Quality and Security Act (DQSA) late last year opens a new chapter. It means greater transatlantic clarity of future compliance requirements and (whether intentional or not) it also brings near synchrony of some key deadlines. Continue reading Sponsored: Transatlantic Alignment
