Regulatory Updates in Brief
This article was originally published in The Gold Sheet
ICH association convenes; ISO revises cleanroom standards; NSF accredited for excipient GMP certification; supply chain library launched.
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The organization that works to harmonize drug review requirements across a growing number of regulatory authorities aims to partner with non-profit groups to train regulatory authorities and industry on its guidelines, starting with guidelines on stability testing, good clinical practice and good manufacturing practices for active pharmaceutical ingredients.
China is imposing tougher – and in some cases unrealistic – requirements for excipient manufacturers, while Brazil is proposing similar new requirements. Confusion abounds with respect to shelf life, expiration dates and retest dates.
The International Conference on Harmonization strengthens the hand of regulatory authorities in consensus-based discussions with industry, while applauding the growing role of non-ICH authorities in its expert working groups.