Tuesday 15 February 2022

Overview of comments on the draft guideline on quality requirements for drug-device combinations


The European Medicines Agency (EMA) has published a set of comments raised in relation to its draft guideline on quality requirements for drug-device combinations.


The guideline describes the information that should be presented in the quality part of a marketing authorisation dossier for a medicinal product when it is used with a medical device. The guideline focuses on product-specific quality aspects of a medical device (integral, co-packaged or separately-obtained and referenced in the product information) that may have an impact on the quality, safety and efficacy of a medicinal product.



The comments can be found here: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-water-pharmaceutical-use_en.pdf


The main document can be accessed here: https://www.ema.europa.eu/en/quality-documentation-medicinal-products-when-used-medical-device


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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