News about GMP/cGMP


EMA: New Concept Paper for Combination Products

According to EMA this concept paper addresses the need for development of a guideline on dossier requirements for medical devices that are supplied along with medicinal products where a device is necessary for administration or localization of the medicinal product.

What are the problems stated?

  • Given the diversity of devices supplied with medicinal products and continuous technical developments data supplied in the dossiers of the marketing authorization applications (MAA) are found to be inconsistent and often incomplete.
  • There is no simple, legal terminology for a device component either being used with a medicinal product or only for its delivery.
  • The number of MAAs and requests for scientific advice for drug-device combinations (DDCs) are steadily increasing, in particular along with the commercially available novel devices with automated functions.
  • Medical devices supplied as integral to a medicinal product, such as pre-filled syringes, inhalers, and auto-injectors, are more complex than container-closure systems, due to the associated delivery and measuring or metering function. Inappropriate use of these devices may compromise the safety and efficacy of the medicinal product and result in adverse drug reactions (ADRs) or medication errors.

The variety of combination products is immense and is referred to as drug-device combination products (DDCs) within the context of the concept paper. The medical device may be

  • supplied as an integral component of the medicinal product (e.g. pre-filled syringe, auto-injector), or
  • supplied separately (co-packaged; e.g. oral syringe, pen-injector), as a non-integral combination with the medicinal product, or
  • marketed  independently (in cases where the device meets  the requirements for the necessary delivery system).

What is the intended scope?

The scope of the guideline will only include human medicinal products. It will not specifically address issues related to integral device as part of combined advanced therapy medicinal products, but it is expected that the same principles will apply. However, quality issues related to devices when used for a delivery function in combined advanced therapy medicinal products (cATMPs) will be covered.

It will provide guidance for pharmaceutical industry, medical device industry and regulatory authorities. Nevertheless, there is no intention on duplication of assessment performed during assignment of CE mark for the medical device.

What is the timetable?

The 5-page Concept Paper will be released for external consultation until 16 May 2017. Following this period, a draft guideline will be prepared and released for a 6-month external consultation. The draft will then be revised taking into consideration the received comments.

With this step, the EMA is following the US FDA who has been regulating combination products seperately since 2013 (21 CFR 4) and released a final guidance on this subject only a short while ago (we already reported).


EMA: Concept Paper