2020-09-15 | FDA 2020 UDI Deadline. Enforcement Postponed for Class I Medical Device

Updated Sept 24 2020.

As of September 24, 2020 Class I medical devices needed to meet the FDA’s Unique Device Identification Final Rule. However, that date was postponed by the FDA in July with the publication of a new Policy Guideline document. That means the FDA will not begin enforcing the UDA Final Rule on these devices until September 24, 2022. By this new date, 

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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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2019-08-07 | 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.

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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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2019-07-10 | 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.

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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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2017-03-17 | The Global Serialization Marathon

By Avi Chaudhuri, PhD, Senior Global Partner

We are currently in the middle of a regulatory marathon—one created to meet the country-by-country guidelines for drug packaging throughout Europe, USA, and several other countries. At Systech, we care about this because the technology platform of choice to accomplish regulatory compliance has been our primary focus for more than twenty years. Systech has been the global leader in serialization-based product traceability ever since the US FDA...

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