News updates from EMA in July and August

11 August, 2017

During July and August, the EMA has published updates relating to the following topics:

  • Mutual recognition agreements, with recent addition of details related to USA (Link)
  • Reflection paper on promotion of pharmacovigilance reporting (Link)
  • ADVENT: Q & A on allogenic stem cell-based products for veterinary use: Specific questions on extraneous agents (Link). Follows on from recently published specific questions on sterility (Link).
  • Draft reflection paper on off-label use of antimicrobials in veterinary medicine (Link)
  • Draft reflection paper on use of aminoglycosides in animals: development of resistance and impact on human and animal health (Link)
  • European Commission requested EMA to update the AMEG categorisation of antimicrobials and to further elaborate on the proposed early hazard characterisation (Link)
  • Analysis of antimicrobial consumption and resistance ('JIACRA' report II) – 2013 – 2015 (Link) - “This new report confirms the link between antibiotic consumption and antibiotic resistance in both humans and food-producing animals.
  • News bulletin for small and medium-sized enterprises - Issue 40 (Link)
  • Contact details of national competent authorities (NCAs) for PSUR submission – updated (Link)
  • United Kingdom’s withdrawal from the European Union ('Brexit') – list of formal bids to host EMA now published (Link)
  • Updated information regarding MRL application submission (Link)
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