2020-03-17 | Coronavirus Tests – A Counterfeiter’s Dream

I have written and spoken about global counterfeiting issues many times. Pretty much in every single one, I’ve said something like “if you have a successful product, it will be counterfeited.” Illicit counterfeit rings have infiltrated pharmaceuticals, consumer goods, cosmetics, fragrances, automobile parts, aircraft parts, clothing, footwear, wine, spirits and more. The riches and rewards from producing and distributing counterfeit products in most cases far outweigh the penalties of getting...

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2020-01-21 | The Return of Patient Safety Teams, Post Serialization

Change is afoot, we are entering a new phase of activity within the pharmaceutical sector. The next stage of patient protection is starting to take shape across the industry, and it is a case of going back to the future. Though, no DeLorean, TARDIS or even a hot tub time machine are needed to make this change, we are not going to have hover boards or give cousin Chuck Berry a new sound. Instead of fighting Daleks we are going to wage war on counterfeiters and grey marketeers.

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2019-11-04 | 2019 GS1 Barcode Assessment Study Results – Pharma Packaging Compliance

It is one thing to mandate the printing of serialized barcodes on pharmaceutical packaging, and quite another to properly print these barcodes on said packaging to meet compliance.

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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 health...

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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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2019-05-13 | 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.

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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.

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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 to...

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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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2018-08-21 | 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 by...

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