EMA Weighs New Guideline on Quality Requirements for Combination Products

Regulatory NewsRegulatory News | 16 February 2017 |  By 

The European Medicines Agency (EMA) on Thursday released for public consultation a new concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product.

EMA says the guideline will consider the data requirements with respect to quality aspects in relation to the safety and performance of the medical device, whether it is an integral component of the medicinal product or a stand-alone device, including usability studies in target patient populations with the relevant clinical conditions.


As the US has sought to better regulate combination products coming to market, the EMA notes an increase in the number of marketing authorization applications (MAAs) and requests for scientific advice for medical devices for delivery or localization of the medicinal product, known in the EU as drug-device combination products (DDCs).

“DDC fitness for the intended purpose (e.g. administration of a medicinal product) needs to take into account the Quality aspects of the device in itself and its use with the particular medicinal product, as well as the complexity of the device component, the patient characteristics, the caregiver characteristics where relevant and the clinical situation in which the DDC is to be used. It is therefore appropriate to provide guidance on Quality data requirements for medicinal products incorporating, or used with, medical devices i.e. DDCs to assessors and pharmaceutical industry,” the paper says.

But unlike in the US where the Food and Drug Administration (FDA) oversees the regulation of drugs and devices, EMA notes that CE marked medical devices are provided separately but sometimes co-packaged with the medicinal product, and assessments are performed by notified bodies, though they “may not fully take into account the characteristics of the specific medicinal product that the device is to be used with. This could have an impact on the overall quality, safety or efficacy of the medicinal product when used along with the specified medical device.”

EMA says this specific aspect of a device is to be addressed in the context of the assessment of the application for marketing authorization and “there is no intention on duplication of assessment performed during assignment of CE mark for the medical device.

“In contrast, in situations where the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, the medical device is not assessed by a Notified Body and assessment of all of the above aspects, including compliance with Annex 1 to the MDD, is conducted as part of the assessment of the application for marketing authorisation."

What’s Ahead

EMA’s Quality Working Party and Biologics Working Party recommend developing a guideline on quality aspects of the dossier requirements for DDCs for MAAs, line extension applications and variations to show that the combination has been appropriately designed and controlled and can be used correctly in the intended clinical situations.

“The scope of the guideline will only include human medicinal products. The guideline should consider the information to be included in product literature (SmPC, Patient information leaflet and labelling) to ensure the safe and effective use of the medicinal product. It should also include the necessary considerations for cases where there is a specific requirement for medical devices for use with the medicinal product (such as nebulisers or anaesthetic delivery equipment) but where these are available separately, often from a different manufacturer. The guidance will not specifically address issues related to integral device as part of combined advanced therapy medicinal products (cATMPs as per Regulation (EC) No 1394/2007) but it is expected that the same principles will apply. However, quality issues related to devices when used for a delivery function in cATMP products will be covered.”

Concept paper on developing a guideline on Quality requirements of medicinal products containing a device component for delivery or use of the medicinal product


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