Developments from the EMA on AMR, eSubmissions and the NVR, but strain of relocation continues to be felt

With ongoing challenges brought by Brexit and associated staff losses at the EMA, resources are being focused on key priorities, such as implementation of the New Veterinary Regulation (NVR).

CVMP adopts new reports on AMR in October plenary meeting

The EMA has posted the press release with details of the CVMP's plenary meeting of 8 – 10 October 2019 (Link). General news relating to regulatory affairs includes:

Antimicrobials and AMR

The Committee adopted a draft reflection paper on ‘Promoting the authorisation of alternatives to antimicrobials in the EU’ for public consultation. This will be published on the EMA website in the coming days.

Relating to implementation of the NVR, the Committee adopted a report concerning the criteria to designate antimicrobials for human use. This will be published shortly on the EMA’s new NVR implementation webpage (Link).

Also related to AMR, but outside the plenary meeting, the EMA has published the latest data from the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) project, which show a 32% reduction in sales of veterinary antibiotics in the EU between 2011 and 2017 (Link). 

Regulatory submission procedures

Validation checklists for initial MA applications for veterinary pharmaceutical and immunological products will be updated soon, providing applicants with the same checklists as used by assessors during validation. These will be published on the EMA website in the coming days.

eSubmissions

New versions of the electronic application forms have been released, to fix various bugs (Link). These forms should be used for all new procedures, but the version of forms used should not be changed during an ongoing procedure.

Implementation of the New Veterinary Regulation (NVR)

The EMA has launched a new webpage showing the progress and schedule for publication of the EMA recommendations on the implementing and delegated acts of the NVR (Link).

Brexit

Continuing staff losses at the EMA due to the Agency’s relocation, combined with additional workload associated with the NVR implementation means that the EMA is reviewing its organisational structure to ensure it meets its key priorities (Link). More information can be expected in due course.

The EU Telematics Group has issued a reminder that, as of 31 October 2019, the UK will no longer be able to access CESP, which will be closed to National Agencies in the UK (Link).