2019-09-10 | Unpacking Indonesia's Pharma Serialization & Traceability Regulations

Indonesia is a country that is a collection of many islands in Southeast Asia. You may not think of Indonesia very often, but you should. Indonesia is the fourth largest country on Earth by population, behind China, India and the United States. It is the 14th largest by land area and the 7th largest when you consider land and water surface. It’s big, and it has been doing well economically for the last decade or so since the government stabilized. And they have a government-run universal...

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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.

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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...

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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...

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2018-12-03 | The Genie is Out of the Bottle ... My Thoughts on the Marijuana Business Conference in Las Vegas

First, allow me to set the stage with some facts:

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2018-10-02 | Reducing the Complexity of Global Pharma Regulatory Compliance

First and foremost, a successful serialization program involves far more than just placing serial numbers on packaging -- regardless of the market. However, pharmaceutical companies that distribute in more than one country face significant regulatory compliance complexity, with each additional market adding another layer of challenges. Regulations differ between markets, and can change often enough meaning regulatory professionals must be prepared to adjust processes, procedures and filings...

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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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2018-06-29 | 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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2017-10-20 | The Lexicon of Serialization: Terms You Need to Know

 

Serialization forms the new basis for the ongoing effort to secure the supply chain—most significantly the pharmaceutical supply chain, but also increasingly in other sectors. However, it is only the foundation on which other technologies are built to add this sought-after security. Serialization goes far beyond placing a number on a box.  These associated technologies, and the terms used to describe them, are explained here.

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