Regulatory Affairs Professionals Society

Pharma groups say SUPAC guidelines should be updated, better aligned with ICH

Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug ...
RAPS

ICH releases draft guidelines on analytical method development

ICH announced on 31 March that both guidelines “are intended to complement ICH Q8 to Q12 Guidelines, as well as on-going ICH Q13 for Continuous Manufacturing, with a view to potentially combine both ...