EMA Quality Guidelines for Drug-Device Combinations (DDCs)

Jun 10, 2019
By M.Turner

The European Medicines Agency has published draft quality requirements EMA/CHMP/QWP/BWP/259165/2019 for delivery devices and other integral and non-integral DDCs.

Non integral DDCs include such things as refillable injector pens, inhalers, and pumps. Examples of integral DDCs are non-refillable items, such as implants.

In addition to design validation testing. areas covered include:

·         Submission of data, its location in the dossier, and its format

·         Platform technology/technologies

·         Scientific advice

·         Product Information

·         Drug Product

·         Adventitious Safety Evaluation

·         Regional Information, Medical Device

·         Non-Integral DDCs with co-packed medical devices

·         Regional Information, Medical Device

·         Non-Integral DDCs with separately obtained devices

·         Bridging to devices used in clinical development

·         Emerging Technologies


Contact MET for support with design validation and batch release testing.

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