EMA launches upgraded eSubmissions gateway and tool for SMEs
This article was originally published in SRA
The European Medicines Agency has launched an upgraded version of its electronic submission channel that pharmaceutical companies can use to submit via the internet their centralised procedure applications for human drugs in the electronic common technical document (eCTD) format1.
You may also be interested in...
The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with three new products including Novartis's Beovu for treating neovascular (wet) age related macular degeneration. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).
Now that the European Medicines Agency has finalized its formal safety review procedure into Xeljanz, Pfizer is telling health care professionals what precautions they must take when prescribing the drug.