EU Variations Proposal Could Make Changes Harder in Some Countries
This article was originally published in The Gold Sheet
RESISTANCE TO CHANGE confronts proposal for EU-wide variations scheme as trade groups and member states defend 'unbureaucratic' status quo. Proposal's quality-by-design component is widely praised, but new 'do and tell' approach to minor changes runs into difficulties. New default category, regulatory worksharing and API changes also discussed
You may also be interested in...
Drug makers win one-month reprieve for their nitrosamine risk assessments for new drug products and approved products.
Technologies like head-mounted tablets became critical for method transfers, virtual inspections and more. Cloud-based submissions could be next …
Post-approval change management protocols could go a long way toward smoothing global rollout of analytical method changes, ICH Q12 expert says.