Deadline Extended: EMA Informs about New Deadline for Risk Assessment on Nitrosamines
The European Medicines Agency, EMA, as well as the EDQM have extended their deadlines for submitting risk evaluations for Nitrosamine Impurities in medicinal products by the Marketing Authorisation Holders.
How to authorize a Combination Product in the USA?
In the USA, combination products are regulated independantly. A draft document from the FDA entitled "Principles of Premarket Pathways for Combination Products" describes the ways in which marketing authorisations are granted in the USA and how the various Centers interact.
EMA/CHMP publishes new Q&A Document on Comparability Considerations for ATMPs
A document on the topic of comparability in the context of Changes and Variations at ATMP, published in December by the EMA, respectively the CAT, completes the series of guidelines and assistance around ATMP.
Guide on the Use of Type V Drug Master Files for Combination Products
In October 2019, the FDA issued guidelines in a draft document regarding the use of a Type V Drug Master File (DMF). In this document, information can be made available to the CDER (if it is in charge of the (project) approval procedure) concerning the medical device proportion of a combination product.