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Concept Paper for Combination Products-EMA

A concept paper on ‘developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medical product’ is released by the European Medicines Agency (EMA). The concept paper advocates 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.

Challenges to frame guidelines:

There are many combination products and is referred to as drug-device combination products (DDCs). This concept paper discusses all those DDCs such as medical devices:

Scope of the Guidelines

This guideline covers only human medicinal products. However, this will not address issues related to integral device as part of combined advanced therapy medicinal products.

 Additionally, quality issues related to devices whenever used for a delivery function in combined advanced therapy medicinal products (cATMPs) will be covered.

The guidelines will provide guidance for pharmaceutical industry, medical device industry and regulatory authorities. Nevertheless, there will be no duplication of assessment performed during assignment of CE mark for the medical device.

Release date for concept paper

On 16 May 2017, a 5-page concept paper will be released for public review. Following this period, a draft guideline will be prepared and released for a 6-month external consultation. After incorporating the comments, the draft will then be revised.

With this step, the EMA is following the US FDA in regulating combination products separately since 2013 (21 CFR 4) and released a final guidance on this subject recently.


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