ICH Enhances Regulators’ Roles While Preserving Industry Access
This article was originally published in The Gold Sheet
Executive Summary
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.
You may also be interested in...
Regulatory Updates in Brief
ICH association convenes; ISO revises cleanroom standards; NSF accredited for excipient GMP certification; supply chain library launched.
In Brief: FDA Fights for Access; ARI Idled; ICH, PIC/S and EU Launch Initiatives
What happens now when plants block FDA inspections; how ARI drug shortage collaboration is falling short; how ICH is reforming; what PIC/S deems a deficiency; and how EU is updating the role of the QP.
Brazil Blazing Trail on Excipient GMPs
Brazil’s ANVISA shows global leadership in regulating pharmaceutical excipients with proposed excipient GMPs. Comments were generally favorable, though there were concerns about the extent of applicability to foreign excipient makers.