EMA announces updates on AMR policy and GMP and issues information on SMEs, Type I variations and recent activity at the EMA

31 October, 2016

Following the publication of the report on the October meeting of the CVMP, the following additional news has been posted by the EMA:

  • Monthly report - The EMA’s September monthly report for veterinary medicines, containing information on application procedures, guidelines and related documents for veterinary medicines, is now available via the EMA website (Link to PDF document).
  • AMR policy - The CVMP has published an updated strategy on antimicrobials following public consultation, and an updated guideline for the demonstration of efficacy for VMPs containing antimicrobial substances. See the EMA’s AMR web page, including links to the adopted strategy and guideline, here (Link). A summary of comments received is also publicly available (Link).
  • GMPThe GMP/GDP Inspectors Working Group has opened consultation on clarifying the available guidance on MAH and manufacturer responsibilities relating to EU GMP. Comments are invited until December 2016 (Link).
  • Type 1 variations - The European Medicines Agency (EMA) is advising marketing authorisation holders to submit any Type IAIN and Type IA variations for 2016 by Wednesday 30 November, to enable a start date prior to the Agency’s closure over Christmas. See the notification here (Link).
  • SME newsletter - Issue 37 of the EMA SME Office’s newsletter is now available online (Link).
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