EMA Finalizes Quality Requirements For Drug-Device Combinations
New EU guidance discusses the quality documentation needed for medicines that contain a device component for their delivery or use.
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Long-awaited draft EU guidance on the quality requirements for integral and non-integral drug-device combination products will be published very soon.
The EMA hopes that the use of a single portal by drug companies and EU/EEA inspectorates to coordinate on good manufacturing practice inspections will drive greater efficiency.