The FDA and international regulators must establish a much more collaborative framework in order to ensure the safety of the world’s drug supply chains, FDA Commissioner Margaret Hamburg says.
“If I can look at a set of inspections from [the European Medicines Agency (EMA)] or Health Canada for my decisions, we’ll all benefit,” Hamburg said in a panel discussion with EMA executive director Guido Rasi and Health Canada’s assistant deputy minister Paul Glover at the 2012 Drug Information Association’s annual meeting Monday.
Countries do not need to have the same standards and checklists to achieve the same results, but they need to ensure the integrity and comparability of outcomes, Hamburg said. And in order to depend on different countries’ regulators, minimum standards need to be established.
Are you a drugmaker with supplier contracts across the globe? Are you aware of the collaboration between international regulators regarding inspections into manufacturing practices and supplier management?
To help you better understand what the FDA, Health Canada and other regulators across the globe are doing to secure a better supply chain, attend FDAnews’ Fourth Annual Supplier Quality Management Congress this July 31-Aug. 2.
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