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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