In late August, the China National Drug Administration (CNDA) posted three new draft guidance documents detailing a proposed National Drug Regulatory Information Standard and Traceability System. Chinese versions of the drafts are available now but the agency is requesting feedback from stakeholders and the public to be submitted by September 20, 2018. Final versions are likely to appear soon after that.
In 2017, the largest market for pharmaceuticals—the United States—delayed enforcement of their key pharma serialization requirement. The revised deadline for serialization and verification here is November 27, 2018, one year later than originally specified by Congress in the Drug Supply Chain Security Act. A few months before that delay was announced, Brazil withdrew their entire regulation, changed their law, and published a more reasonable timeline that would result in full serialization by...
A few months ago, the government of the Russian Federation adopted Order Number 791-r, which appears to have significance for pharma serialization there. The primary deviation from the pharma serialization specification that has dictated the government pilot in Russia since early 2017 is the addition of two new data elements to the datamatrix barcode on secondary packaging. For the pilot, the datamatrix barcode contained:
Vincent Willem van Gogh is remembered as the quintessential tragic artist, having been relatively unsuccessful during his life and plagued by mental illness. While staring at the gardens out the window of the Saint-Paul asylum, could van Gogh even begin to comprehend the idea that some of his final works would be among his most famous and fetch prices upwards of $80M at auction? Could he even understand that his life, his techniques and body of work would be studied and treasured? Could he...
India is on the cusp of introducing a new serialization program for domestic pharmaceutical products. Indian officials have designated this new initiative as a track and trace program though it appears from media reports that the proposed mandate will instead be aimed at creating a consumer-based authentication program. The idea is to print a unique serial number on drug packages so that consumers may authenticate the product via an SMS- or call-enabled mechanism to verify the code.
There are...
The European Union Intellectual Property Office (EUIPO) has just released a comprehensive report on counterfeiting and Intellectual Property Rights (IPR) infringement in the European Union.
Do you remember when the Beatles released Rubber Soul? Not being alive in 1965 meant I was unable to experience this first hand, but as an avid fan I've done some research so bear with me for a minute. The album arrived as a shock, it was unlike anything the public had heard before. It was a dramatic departure from their previous material and the band's maturity was perceptible in their songwriting and lyrical content. While fans initially struggled to wrap their heads around what they were...
There is a sharply polarized view within the healthcare industry as to whether blockchain is the holy grail or Dante’s 1st circle of hell. This truly hyper-partisan view of a technology leaves us all scratching our heads on what to believe.
Blockchain, as a technology, has the potential to redefine how business is conducted. Its capacity to be a trusted and secure digital record or ledger has significant real-world applicability. Many different industries are ripe for disruption including any industry involved in supply chain operations. One industry that looks prime for the adoption of blockchain is pharmaceuticals.
From now through November 2020, the deadlines for meeting the Drug Supply Chain Security Act (DSCSA) happen every year. The pace of change has accelerated and companies need to remain vigilant to stay compliant. Fortunately, there are three important new DSCSA resources that became available in the last two weeks.
