Tag Archives: Traceability

Dawn of HDA’s Origin, The Key to DSCSA Compliance

This week at the Healthcare Distribution Alliance (HDA) Distribution Management Conference and Expo (DMC) the HDA and ValueCentric will provide much more detail around the new master data sharing service they plan to make available in July.  The new service—named “Origin”—is intended to provide members of the pharma supply chain with a single directory of master data for all prescription drugs marketed in the United States (see Origin website).  That is, it is a database of master data wrapped within a cloud-based service. 

Origin master data is composed Continue reading Dawn of HDA’s Origin, The Key to DSCSA Compliance

ANVISA Reveals Draft Serialization Regulation and Asks For Comments

Last week, the National Agency of Sanitary Surveillance (ANVISA), the healthcare regulator in Brazil, published a draft of their proposed pharma serialization regulations aimed at meeting the requirements of the new law number 13.410 of December 28, 2016 (see “Brazil Gets Rational With Their New Pharma Traceability Law”).  The purpose of this new publication is to solicit comments from interested parties.  It is called “Public Consultation No. 311 of February 15, 2017”.  This is not a final regulation—the public consultation ends on March 17, 2017, after which changes to the text, based on the feedback collected, are likely before it becomes final—but it provides us with a solid view of ANVISA’s thinking, and that amounts to a big win for the industry, and for Brazil.  Now is the time to read it over and submit your comments to help make it even better. Continue reading ANVISA Reveals Draft Serialization Regulation and Asks For Comments

China’s Retreat From Pharma Serialization: Will This Become A Global Trend?

istock_102889873_smallerChina once had one of the most aggressive pharma serialization mandates of any market.  Their compliance timeline began in 2007 with a list of “essential drugs” and ended in January of this year when, effectively, all drug packages were required to carry a unique serial number.  Shortly after that milestone the government suspended that requirement, pending a new regulation.  Since that time the China Food and Drug Administration (CFDA) has posted several documents related to their new plans (see “China Adds Traceability Requirement To CFDA Drug Quality Management Specification”).  Last month a new notice from the CFDA Continue reading China’s Retreat From Pharma Serialization: Will This Become A Global Trend?

China Adds Traceability Requirement To CFDA Drug Quality Management Specification

CFDA.logoEveryone who markets drugs in China has been watching for the publication of revised requirements for tracing drugs there since the government apparently suspended their previous requirements earlier this year.  Interpreting Chinese government announcements is very hard to do.  Even knowing for sure exactly what has been suspended about the previous regulation is very difficult.  Google Translate does a poor job of making Chinese understandable enough to provide me with confidence.

With all that said, a few weeks ago a notice appeared Continue reading China Adds Traceability Requirement To CFDA Drug Quality Management Specification

Sponsored: Tracking Serialization: 2016 Pharma Trace Market Trends

Tracking Serialization titleDo you know what situation your peers’ businesses are in, and what they’re working to?  To find out just that, IQPC polled their network of pharmaceutical serialization professionals and got responses from representatives of over 20 companies.

The results?  Most find data storage and management to be their biggest issue, citing ERP systems as some of their biggest investments in 2016 and going forward.  It follows that over 50% of those we polled are either implementing their strategies in multiple sites or already done and thinking beyond compliance.

IQPC also asked about their biggest inhibitors, their current and future budgets, and their experience with international compliance.  If you want to find out what your peers think about these topics, you can download the survey report, or meet them on-site at the Pharmaceutical Traceability Forum, May 23 – 25 in Philadelphia.  Use the discount code PT_RXTRACE to get 20% off the standard price! Continue reading Sponsored: Tracking Serialization: 2016 Pharma Trace Market Trends

Sponsored: The 2016 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz, Final Report

Cover thumbnailThe final report of the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz is now available.  Download the full free report here.  With this year’s survey we attempted to get a glimpse of the progress toward the next deadlines of the Drug Supply Chain Security Act (DSCSA) from drug manufacturers, repackagers, wholesale distributors, 3PLs and dispensers.  Each of those different types of respondents were asked a different set of questions that were pertinent to their segment and their regulatory requirements under the DSCSA.

Frequentz.logoTake a close look at the results.  They reveal that Continue reading Sponsored: The 2016 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz, Final Report

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

iStock_000008540261SmallerThose 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