2018-09-06 | China Announces New Drug Traceability Regulations.

In late August, the China National Drug Administration (CNDA) posted three new draft guidance documents detailing a proposed National Drug Regulatory Information Standard and Traceability System.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.

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2018-08-21 | Egypt, India and Pakistan Delay Their Pharma Serialization Deadlines

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...

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2018-07-18 | Russia Flirts with A ‘Crypto Code’

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:

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2018-06-29 | Blockchain : Insanity or Genius?

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...

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2018-06-22 | False reassurance—the real danger behind India's new pharma serialization proposal

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...

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2018-06-18 | EU Counterfeiting: Alive and Kicking Still

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.

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2018-05-04 | From Abbey Rd. to Blockchain Blvd.

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...

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2018-04-13 | Blockchain may be ready for healthcare, but is healthcare ready for blockchain?

 

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. 

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2018-04-06 | Serialization and Line Validation – the Impacts

One of the often-forgotten facets of a pharmaceutical serialization project is the requirement to revalidate the packaging line and process during implementation.  If companies need to purchase and implement new equipment to accommodate serialization, revalidation is expected.  But, like many companies, if retrofitting of existing equipment takes place, validation may not be thought of early enough in the project.  In either case, you may end up in a rush to write and execute several...

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2018-03-23 | Blockchain is here, real, and ready for the Pharmaceutical supply chain

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.

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