2019-08-26 | Systech Radio: The FDA Pilot Program Explained

 

Earlier this year, the FDA called on the life sciences and healthcare industry to design and deliver pilot projects for an electronic, interoperable system that can identify and trace prescription drugs as they are distributed across the United States in support of the DSCSA. Systech partnered with several industry innovators to respond to the FDA’s proposal including RxTransparent, T-Systems, FarmaTrust, CryptoWerk and CalQLogic.

Read more »
2019-08-07 | Systech Radio: Unpacking the VRS Mandate

The US pharmaceutical industry has been all abuzz about the upcoming VRS Mandate on November 27, 2019. If this is news to you, you may want to start here.

Read more »
2019-07-31 | China Accelerates Pharma Traceability Regulations in New Document

China’s National Medical Products Administration (NMPA) has been very active in the last year, producing documents that address various aspects of their planned pharma traceability mandate. It has been several years since the previous pharma serialization and tracing regulation was suspended. The future system described in the new final guidance documents is significantly different from that old suspended system. Where the old system avoided the use of global standards—and thus it was a...

Read more »
2019-07-24 | Counterfeiting and Diversion is Booming in China … So I went to AIPIA Shanghai

Did you know that 80 percent of the world’s counterfeit goods come from China? Everything including luxury goods, cosmetics, wine and spirits, medicine and more are vulnerable to duplication and sometimes the fakes are so similar that it can be hard to determine the real from the phony. With that being said, brand owners across the globe view China’s counterfeiting business as a threat to their own.

Read more »
2019-07-10 | Verification Router Service Solves 2019 DSCSA Mandate

The Drug Supply Chain Security Act (DSCSA) contains a series of escalating mandates for companies in the pharmaceutical supply chain. Each deadline falls on the anniversary date of the law’s adoption on November 27, 2013. For 2019, one of the new requirements is for wholesale distributors to begin verifying saleable returns using the Standardized Numerical Identifier (SNI) before they can redistribute them.

Read more »
2019-06-24 | Russia: The Deadlines Are Almost Upon Us and The Clock Keeps Ticking

The deadlines for the pharma labeling system (cryptographic serialization and tracing system) MDLP, in the Russian Federation are fast approaching. Companies marketing drugs in the Russia Federation targeting seven named nosologies must register with CRPT, the governments service provider, by July 8, 2019. Then on October 1, 2019, packages of drugs targeting those seven named nosologies must be serialized according to very Russia-specific technical guidelines, and production and shipments...

Read more »
2019-05-13 | Serialization and Beyond: A Post-Webinar Wrap-Up – Part Two

This the second and last part of the Serialization and Beyond webinar wrap-up. You can find the first part here.

Read more »
2019-04-25 | State of Emergency: Health and Beauty Counterfeiting and Diversion

There used to be a time when one could discern a fake cosmetic product from an authentic one by just examining the package. Certain external characteristics—or flaws—like a misspelled word or a flimsy material would give it away. Now, printing and imaging technology has evolved and become so inexpensive that counterfeiters can easily obtain it to create packaging that fools even the savviest consumer. Third-party sellers online like Amazon, Jet.com and other smaller e-retailers have made it...

Read more »
2019-04-18 | The PDSA's New DSCSA Governance Proposal Explained

On March 25, 2019 the Prescription Drug Security Alliance (PDSA) published the first of three white papers that describe their proposal for establishing a new, non-profit governance organization that would be responsible for ensuring interoperability of the Drug Supply Chain Security Act (DSCSA) solutions. This first paper is called “A Proposal: Governance for DSCSA Phase II Interoperability”. In addition, PDSA also published another paper called “An Overview: PDSA Vision for Phase II...

Read more »
2019-04-11 | Serialization and Beyond: A Post-Webinar Wrap Up – Part One

Systech has been conducting educational webinars on important market issues for many years now. Much of this has centered on getting our customers the information they need to meet major pharmaceutical serialization requirement mandates in the United States (DSCSA) and the European Union (FMD). Now, with these mandates “live”, customers are looking at value beyond compliance in their serialization environments and investments.

Read more »