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?
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
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