The EMA has posted the press release with details of the CVMP's meeting of 13 – 15 March 2018 (Link). General news from this press release and other news items relating to regulatory affairs includes:
New fees came into force on April 1st 2018: the updated explanatory note is available to access and download online (Link).
The newest version of the VNeeS checker, relating to the latest revisions to the e-submissions guideline entering into force on 1 September 2018, has been published (Link).
An updated version of the eSubmission Gateway XML delivery file user interface is now available (Link). One of the new fixtures will be introduction of Brexit Related procedure indicator; users can indicate if the change is a Brexit-related procedure.