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In June, the European Medicines Agency (EMA) launched a public consultation on the basis of a draft guideline discussing the ‘Quality requirements for drug-device combinations’. The draft guideline provides guidance on the documentation expected for Drug-Device Combinations (DDCs) in the quality part of the dossier for a marketing authorisation- or a variation application.

The types of DDCs within the scope of this guideline are medical devices integral to the medicinal product, such as inhalers, co-packaged with the medicinal product or referenced in the medicinal product information and obtained separately.

EFA welcomes EMA initiative on DDCs

EFA welcomes the EMA initiative towards the streamlining of quality requirements for DDCs, a type of products that has seen a rise in the number of applications for commercialisation and therefore, usage.

DDCs of great importance for allergy, asthma and COPD patients

DDCs are of great importance for our patient community, given that allergy, asthma and COPD are chronic non-communicable diseases that need long-term medication. Treatments for allergy and airways diseases require regular and correct dosing of the medicine intake.

Increasing availability of DDCs beneficial for people living with chronic diseases

EFA appreciates the increasing availability of DDCs, as their automated features fit well with the long-term needs of allergy, asthma and COPD disease management. Certain DDCs are also vital in life-threatening situations e.g. adrenaline auto-injectors in the case of anaphylactic reaction.

EFA response to EMA public consultation on DDCs

Thanks to extensive consultation with our members, but also through valuable input by our partner organisation, the International Primary Care Respiratory Group (IPCRG), EFA submitted a response highlighting among many others the following aspects:

  • The list of examples should also highlight nasal sprays (integral), epicutaneous patches (integral) and Portable (medical) Oxygen Concentrators (non-integral), the use of which is expanding, among others thanks to information made available by national patient associations.
  • It is important that graphic information on DDCs is available, and that such information is a result of a collective effort involving healthcare professionals, the pharmaceutical industry, patients, but also interdisciplinary workers such as physicians, nurses, and informal care givers.
  • EMA should put an effort in solving the issue of contradictory leaflet information in same devices. There have been several cases in the past where package information did not match between similar products e.g. nasal sprays, inhalers.
  • Patients should be called to offer their experience-based input on issues such as the usability of the drug product.
  • EFA notes that the advancement of science and technology for medical devices does not go hand in hand with the one for medicinal products, affecting the compatibility between devices and drug products. Especially in our disease areas, patients witness extensive developments in the field of devices e.g. smart inhalers, air purifiers etc., without necessarily taking fully into account the progress in medicinal products. EFA thinks that this asymmetry in the case of DDCs creates more immediate uncertainties for patients than solutions.

The full EFA response to the EMA consultation on DDCs is available here.

We deeply thank our Members and the International Primary Care Respiratory Group for their contributions in putting this response together.