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.
Following the adoption of the ICH Q12 Guideline in November 2019 the EMA recently published the ICH Q12 Step 5 Guideline and its annexes - together with an Explanatory Note.
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.
New GMP Guidance for Marketing Authorisation Holders
After long discussions, EMA has published a Reflection Paper on Good Manufacturing Practice and Marketing Authorisation Holders summarizing various MAH GMP-responsibilities.
France Takes Further Steps Regarding Medical Cannabis
The French National Agency for Medicines and Health Products Safety carries on the work on medical cannabis started in 2018 and has now published a dossier on cannabis for medical use.
During the transition period, all EU laws remain applicable in the UK. Does that mean that QP certification by UK QPs will still be valid across the EU? Not really, as a statement by the EQPA explains.