Executive Briefings

Big Regulatory Changes Coming to All Players in Pharmaceutical Industry

The times they are a changin' for the players across pharmaceutical supply chains, from API suppliers to CMOs, to manufacturers, packagers, distributors, dispensers/pharmacies ... just about everyone across the chain.

Big Regulatory Changes Coming to All Players in Pharmaceutical Industry

Over the next few years, they are facing a bevy of deadlines for compliance with new regulations around the globe by governments attempting to ensure the integrity, efficacy and authenticity of their nations' pharmaceutical supply. By 2018, over three quarters of the world's legal drugs will fall under one or more of these regulations.

The cumulative mandates from these regulations create a relentless schedule and series of deadlines for the various supply chain participants.

In the United States alone, the DSCSA (Drug Supply Chain Security Act), part of the Drug Quality & Security Act, sets a series of milestones over several years mandating a unique (e.g., serialized) product ID on prescription drug packaging, tracing of drugs from manufacturers through each step to the primary pharmacy, ability to detect and quarantine suspect drugs and notify the FDA, and licensing of 3PLs handling pharmaceuticals. 

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Over the next few years, they are facing a bevy of deadlines for compliance with new regulations around the globe by governments attempting to ensure the integrity, efficacy and authenticity of their nations' pharmaceutical supply. By 2018, over three quarters of the world's legal drugs will fall under one or more of these regulations.

The cumulative mandates from these regulations create a relentless schedule and series of deadlines for the various supply chain participants.

In the United States alone, the DSCSA (Drug Supply Chain Security Act), part of the Drug Quality & Security Act, sets a series of milestones over several years mandating a unique (e.g., serialized) product ID on prescription drug packaging, tracing of drugs from manufacturers through each step to the primary pharmacy, ability to detect and quarantine suspect drugs and notify the FDA, and licensing of 3PLs handling pharmaceuticals. 

Read Full Article

Big Regulatory Changes Coming to All Players in Pharmaceutical Industry