Cyton Germany is now open for business!
Providing all the services available from Cyton UK, the new office ensures business continuity, post Brexit and beyond, for Cyton and our clients.
Although the May meeting of the CVMP remained quiet in terms of guidance documents, due to Brexit related business continuity planning (BCP), there have been other updates from the EMA relating to electronic submissions, the ITF, regulatory submissions and post authorisation best practices for VMPs.
The EMA has posted the press release with details of the CVMP's meeting of 21 – 22 May 2019 (Link). No new guidance documents were adopted at the meeting, but the committee re-elected Ireland’s David Murphy as chair for another 3 years.
A recording of the webinar held on 7th May, regarding CESSP phase 1, is now available online (Link). A second webinar was also held on 5th June, aimed at regulators.
The annual reports for the whole Agency (Link) and from the SME office (Link) have been published. Both of these reports provide a summary of the veterinary activity and the EMA annual report highlights the impact of Brexit BCP on progress at the agency.
The EMA Innovation Task Force (ITF) is now available for anyone developing critical antibacterial or antifungal products (Link). ITF meetings are free of charge, but how accessible this extension will be to developers of veterinary medicines is not clear, as it is stated that any new medicinal product for the treatment of a life-threatening or debilitating fungal or bacterial infection would be considered.
Various Q & A webpages have been extensively revised and it is recommended that any experts in the respective areas review these updated Q & As carefully, to understand the latest in best practices. The following webpages have been updated: