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...
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.
Pharmaceutical manufacturers should have already begun serializing products and verifying saleable returns to comply with DSCSA, says FDA official who also asserted that licensing standards for wholesale distributors and third-party logistics providers will be forthcoming. This rule is already six years overdue under a DSCSA mandated timeline.