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.”
http://blog.pharmtech.com/2012/04/05/pooling-resources-to-strengthen-supply-chain-security/
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