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The pharmaceutical industry faces complex issues in ensuring patient safety. It must test and provide safety and efficacy profiles on its prescription drugs during clinical trials and throughout the product lifecycle. It must adhere to strict quality control procedures in manufacturing to meet safety guidelines, and then maintain the safety of the product throughout distribution. To do all of this effectively, the industry is facing a new regulatory challenge – that of product serialisation. How the industry meets this challenge will be the defining factor for years to come in how it secures the safety of the patient and supply chain.