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Preparing for a Safety Inspection

Title
Preparing for a Safety Inspection

Abstract
Large and small pharmaceutical companies alike face a growing and complex set of international regulations designed to protect patient safety and ensure good pharmacovigilance practices. Inspectors from FDA and European regulatory authorities are increasing their efforts to verify that companies comply with these regulations. The penalties for noncompliance can be severe, including revoking a product’s marketing authorization. In my experience, European safety inspections (particularly those conducted by the Medicines and Healthcare Products Regulatory Agency, MHRA) are more thorough than FDA inspections, holding companies to a higher standard of pharmacovigilance. While FDA inspections are very detail oriented, European inspections tend to look for the big picture, and want to find that companies are taking an integrated, global approach. It is also the case that while FDA inspectors may cover many areas of compliance, European safety inspectors tend to be specialists in this field. To prepare for an inspection, companies must perform a thorough drug safety and pharmacovigilance audit. This will assess the company’s compliance with applicable worldwide laws, regulations, and guidance. Indeed, regulatory inspectors will look for evidence that such an audit has taken place. I recommend that all companies arrange to have an independent audit of their entire safety operations to prepare for a regulatory inspection. This article is designed to give companies operating in the United States and EU the information and insight needed to ensure compliance with global drug safety and pharmacovigilance regulations. It addresses the most recent drug safety regulations from both FDA and the European Medicines Agency (EMA).