EMA Updates Guidelines on Excipients in Labeling
On October 9, 2017, the European Medicines Agency (EMA) announced that the annex to the guideline on excipients in labeling and packaging of drug products has been updated to include all excipients that must be listed in the labeling and packaging leaflets of drugs and their safety warnings.
The guideline was updated to take into consideration safety concerns not currently addressed in the existing annex, with specific attention to excipients that may affect children or pregnant women. Five new excipients are included, and 10 have been updated with new safety warnings.
Source: EMA
|
|---|
|
Columnists
Webcasts
Outsourcing
Catalent Expands Biologics Packaging Capabilities at Indiana Site
The company is investing approximately $14 million to expand biologics packaging capabilities and capacity at its biologics manufacturing facility in Bloomington, IN.
QPS Expands US-Based Phase I Clinical Trial Capabilities
The contract research organization has increased its US-based early phase clinical capacity and doubled its specialty lab space.
Barriers and Solutions to Effective External Collaboration in Biopharma
As biopharma companies rapidly change their focus, they may lack the laboratory space, instrumentation, and the scientific knowledge to support biologics research.
Sponsored Links
