Pharma companies are spending a boat-load of money to put serial numbers on their drug packages and homogeneous cases, and collecting aggregation data for the wholesale distributors. And in every one of those companies, their leadership is asking, “What can we do to get some value, beyond compliance, from our investments? Can we sell someone some data? Can we get some new business advantage? Can we get some new insight into our processes or into the operation of the supply chain?” Continue reading Sponsored: Brand Protection: The ‘No Brainer’ Value, Beyond Compliance
One Immediate Impact of President Trump On The FDA
Most RxTrace subscribers are aware that the FDA is way overdue to publish four guidance documents mandated by the Drug Supply Chain Security Act (DSCSA) (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?” and “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?” for a list of the missing documents). Two of those four documents could impact how some drug manufacturers deal with the November 27, 2017 deadline for full serialization of prescription drug products, depending on what the FDA says in them.
Every day since the original due date of those documents (November 27, 2015) I have Continue reading One Immediate Impact of President Trump On The FDA
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
Sponsored: RxTrace to Sponsor the 2017 UDI Conference – June 7 & 8 in Baltimore, MD!
One of my favorite conferences each year is the annual Unique Device Identification (UDI) Conference put on by the Clarion Group on behalf of the Food and Drug Administration (FDA). I am happy to sponsor the event each year, and I try to attend when I can.
As an educational authority on UDI, the 9th annual UDI Conference will Continue reading Sponsored: RxTrace to Sponsor the 2017 UDI Conference – June 7 & 8 in Baltimore, MD!
HDA’s 2016 Serialization Readiness Survey
Because of all the major news and developments over the last six months, it has taken me way too long to fully cover the Healthcare Distribution Alliance’s (HDA’s) 2016 Serialization Readiness Survey of drug manufacturers. In my defense, I did cover it partially in my report of the HDA 2016 Traceability Seminar (see “HDA Delivers Home Run To Record-Breaking Audience”), but the other news from that event seemed to overshadow the survey results. The HDA survey executive summary was so well done, and the results so important that it deserves closer scrutiny. So here is my coverage, better late than never. Continue reading HDA’s 2016 Serialization Readiness Survey
Russia Begins Its Pharma Supply Chain Pilot
Last week, GS1 Healthcare raised the awareness of new documents available on the Russian Federation government website. Actually, the news was contributed to that group by Brian Daleiden of TraceLink, who has been very generous with contributions of news and documents from multiple markets. These Russian documents explain the basis for a voluntary pharma supply chain pilot that the government is beginning this quarter. Of course, these documents are only provided officially in the native Russian language. Continue reading Russia Begins Its Pharma Supply Chain Pilot
Sponsored: Monitor Your Product. Manage Your Brand.
Dear Colleague,
We recognize that counterfeit and grey market products pose tremendous risks, both to consumer safety and to your business’ bottom line. The 6th Pharma Anti-Counterfeiting & Brand Protection Summit takes a comprehensive approach to understand the latest regulations for the DSCSA to remain compliant and uphold quality through brand protections plans, anti-counterfeiting strategies, and effective partnerships.
Key Highlights for 2017 include: Continue reading Sponsored: Monitor Your Product. Manage Your Brand.
The Intrigue Contained In The New China Drug Code
Over the last few weeks, the pharma serialization and tracing landscape has begun to shift in China. The China Food and Drug Administration (CFDA) announced a new use for an existing “National Drug Code” in Public Notice 2017-1 that, according to Google Translate (a helpful but very imperfect translator), will be referred to as the “Bit Code”. In addition, a new notice has appeared on the AliHealth-hosted web portal that drug companies have been using for the last seven years or so to obtain serial numbers for their drug packages. Automated translation tools leave too much to speculation so companies should not use them for compliance purposes. However, here are my thoughts/speculation on what is happening. Continue reading The Intrigue Contained In The New China Drug Code
