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With around 80% of APIs manufactured outside the US, many in developing nations without strong regulatory oversight.
With around 80% of APIs manufactured outside the US, many in developing nations without strong regulatory oversight, ensuring the quality and safety of the US’s drug supply is a herculean task. FDA has already taken steps to increase the number of overseas inspections, but it is impractical to assume that one agency is capable of inspecting the world’s manufacturing operations on its own. The Institute of Medicine released a report on Apr. 4, 2012 outlining several practical steps that FDA could take to strengthen supply-chain security.
One recommendation that stands out is that regulatory bodies in developed nations should work together to plan inspections and pool data, and should develop a harmonized set of inspection requirements so that inspections made by one country do not have to be repeated by other countries. According to the accompanying press release, “The report urges FDA and its technologically advanced counterparts in the European Union, Canada, Japan, Norway, Iceland, Switzerland, Australia, and New Zealand to plan a system for mutual recognition of one another’s inspections, which would eliminate the wasteful duplication of effort. There is no need for American and European inspectors to examine the same facilities, especially when a vast number of facilities go uninspected.”
FDA has already begun the process of data sharing with regulatory bodies in Europe, the UK and Australia. A pilot program ran between 2009 and 2011 that resulted in the exchange of nearly 100 inspection reports and in nine collaborative inspections, according to an FDA press release. At the end of the pilot program, FDA released its Pathway to Global Product Safety and Quality, a roadmap to continue the collaborative approach to assuring the safety of globally-sourced products. However, FDA’s blueprint falls well short of the recommendation of shared inspections put forth by the Institute of Medicine.
It’s clear that no one country can inspect every plant in the world. But by pooling their resources, countries with similar regulatory requirements could accomplish a lot more than any one could accomplish alone.