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APEC Supply Chain Regulatory Harmonization Effort Gaining Traction

The Asia Pacific Economic Cooperation (APEC) organization is developing and implementing a five-year plan cutting across GMPs, GDPs, pharmacy practices and Internet sales that could have a powerful influence on global regulatory harmonization in the pharmaceutical supply chain arena....

FDASIA Title VII Implementation Priorities and Action Plans Taking Shape

FDA has been sorting through the multi-faceted supply chain provisions of Title VII of the FDA Safety and Innovation Act (FDASIA) to identify which should be tackled first and to put action plans in place to implement them....

EDQM Launches Harmonized Serialization Program eTACT to Strengthen Europe’s Anticounterfeiting Efforts

On January 26th and 27th, the European Directorate for the Quality of Medicines & Healthcare (EDQM) officially launched its “eTACT” anti-counterfeiting IT-based traceability service with a workshop and live demonstration at its Strasbourg, France headquarters....

EC Publishes Concept Paper on Safety Features to Support Falsified Medicines Legislation

In mid-October, the European Commission (EC) published a concept paper for public consultation on proposed requirements for “safety features” for medicinal products as part of its implementation of the EU falsified medicines legislation. Comments are due by April 27, 2012....

Anticounterfeiting Initiatives on Criminal Penalties and Serialization Advance in the US and Europe

Lawmakers in the US and Europe are moving forward with initiatives to significantly increase criminal and monetary penalties for the manufacture and distribution of counterfeit drugs and to create an internationally-harmonized serialization system....

Congressional Bills Address FDA Supply Chain Oversight

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Complying With Serialization Mandates Requires Long Lead Times, Experts Warn

Serialization experts are warning pharma companies that compliance with looming serialization requirement deadlines will require long lead times....

GS1 Global Standards Gaining Traction as Drug Serialization Deadlines Loom

GS1’s globally harmonized serial number approach continues to gain traction as pharmaceutical manufacturers seek to navigate the complicated maze of international regulatory requirements and comply with their looming deadlines....

California’s Findings of Gaps in Heparin Recalls Highlighted at FDA Track and Trace Workshop

Evidence of the gaps in the 2008 heparin recall process uncovered by the State of California underscores the need for a track and trace system for prescription drug products, CA State Board of Pharmacy Executive Officer Virginia Herold maintained at an FDA-sponsored public workshop on February 15-16 at its White Oak, MD campus....

Cooperative Supply Chain Integrity Efforts Important to Support Advancing Track-and-Trace/Authentication Technologies and QC Analytical Methods

Broad-based cooperation vertically across the supply chain and horizontally across organizations and regions is important to help support the advancements in track-and-trace/product authentication technologies and QC analytical methods, CDER compliance official Richard Friedman emphasizes....
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