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The ICH and other globally focused organizations are working diligently to introduce more consolidated forms of quality regulations, like the ICH Q10, for the management of the quality of drugs related to cold chain distribution and drug security.

It is now approaching 2 years since the Chinese FDA began a push to adopt their proposal for regulations around Good Supply Practices (GSP) within China.

Although these regulations closely mirrored the EU GDP guidelines, and were focused on a ‘risk approach’ to managing quality, the expectation is for full adherence of these new regulations by the end of 2015.